Device Malfunction Research Articles

Current evidence on artificial intelligence in regional anesthesia

The recent advancement in regional anesthesia (RA) has been largely attributed to ultrasound technology. However, the safety and efficiency of ultrasound-guided nerve blocks depend upon the skill and experience of the performer. Even with adequate training, experience, and knowledge, human-related limitations such as fatigue, failure to recognize the correct anatomical structure, and unintentional needle or probe movement can hinder the overall effectiveness of RA. The amalgamation of artificial intelligence (AI) to RA practice has promised to override these human limitations. Machine learning, an integral part of AI can improve its performance through continuous learning and experience, like the human brain. It enables computers to recognize images and patterns specifically useful in anatomic structure identification during the performance of RA. AI can provide real-time guidance to clinicians by highlighting important anatomical structures on ultrasound images, and it can also assist in needle tracking and accurate deposition of local anesthetics. The future of RA with AI integration appears promising, yet obstacles such as device malfunction, data privacy, regulatory barriers, and cost concerns can deter its clinical implementation. The current mini review deliberates the current application, future direction, and barrier to the application of AI in RA practice.

Abstract 4136286: Safety Events with a Large-Bore Aspiration Thrombectomy Device for Pulmonary Embolism: An analysis of the U.S. Food and Drug Administration Manufacturer and User Facility Device Experiences from 2018 to 2024

Introduction: Large bore thrombectomy is increasingly used to treat acute PE. Post-market surveillance using the U.S. FDA Manufacturer and User Facility Device Experience (MAUDE) database may capture serious device adverse events (AE) not described in small pre-market clinical trials. We aim to analyze serious AE associated with use of the Inari Medical (Irvine, California) large bore thrombectomy system to treat PE. Methods: All MAUDE events between January 1, 2018 and May 1, 2024 involving PE treatment with Triever and Flowtriever devices were reviewed and categorized based on device type, incident year, and clinical event. Based on narrative description, AE were placed into categories of cardiac, pulmonary, device malfunction, anemia, and other. Results: A total of 58 AE reports representing 50 unique clinical episodes were included. MAUDE event types were death (n=32), injury (n=23) and malfunction (n=3), and the majority (45/58) involved the larger aspiration catheters (Table 1). Death occurred in 27 of 50 unique episodes. Cardiac injury (n=19) and pulmonary injury (n=18) were most common and included 25 serious perforations. Serious AEs are listed in Table 2. Device malfunction/improper use was rare (n=7) and was not associated with death. Paradoxical embolism was described causing stroke and coronary occlusion. 3 of 4 blood loss AEs occurred prior to 2021. Conclusion: This report includes the largest description of reported AEs with large bore aspiration thrombectomy systems used to treat PE. This report describes serious events, often associated with death, that are likely infrequent and were not detected in pivotal studies or registries. Understanding these AEs may guide future technique and device refinement, and the current findings demonstrate the importance of large post-approval studies.

Abstract 4146315: Complications Associated With the 4798 Attain Stability Active Fixation Coronary Sinus Lead: Insights from the MAUDE Registry

Background: The Attain Stability Quad 4798 [Medtronic, Minneapolis, MN] lead was recently developed with a mechanism for active fixation into the venous wall, allowing for precise and secure placement in coronary venous branches. However, real-world data regarding complication rates are limited. Research Question: What are the real-world complications of the Medtronic 4798 lead? Goals: We reviewed the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for adverse events associated with the 4798 lead. Methods: We reviewed the MAUDE database on November 15, 2023, for all reported complications due to the 4798 lead from January 1, 2018 – a year before the lead was approved by the FDA – to the present. Results: A total of 2011 reports of adverse events occurred in mostly males (67.9%) patients with an average age of 70.86±12.1 years. Leads were used most frequently in 2023 (32.3%) for initial use (65.5%) but events commonly occurred intra-procedurally (73.7%). Device malfunction occurred in 43.4% of cases and included but was not limited to adverse events without an identified device problem (33.9%), device dislodgment (24.1%), infection (21.1%), and failure to capture (18.4%). In several cases, the guidewire was stuck (10.7%), or lead dislodgement (27.9%) occurred, resulting in direct helix damage (10.1%). Malfunctions resulted in injury and death in 55.8% and 1.1% of cases, respectively. Conclusions: The use of an active fixation CS lead has been associated with a significant incidence of intraprocedural helix mechanism malfunction. Further real-world surveillance and registry data can help clarify the true incidence of lead failure.

Numerical simulation of individualized flow diversion cerebral aneurysms treatment

AbstractFlow diverter implantation has emerged as a highly effective treatment for cerebral aneurysms. However, the variability in patient‐specific vascular anatomy necessitates detailed pre‐operative planning to mitigate potential complications arising from standard, one‐size‐fits‐all devices. To address these challenges, robust predictive simulation tools are essential for optimizing flow diverter design and implantation strategies tailored to the unique characteristics of each patient's anatomy. This study focuses on developing an advanced numerical simulation tool for modeling the mechanical behavior of braided flow diverters during crimping and navigation through patient‐specific vasculature. Using isogeometric analysis (IGA) with NURBS‐based representations in LS‐Dyna, the intricate deformations of the flow diverter wires during catheter crimping are captured with high accuracy. The patient‐specific vessel geometries, derived from imaging data, are integrated into the model to account for variations in vascular structure, ensuring precise alignment and controlled navigation of the device. The navigation process relies on optimizing the central axis of the blood vessel to minimize torsional stress on the flow diverter, reducing the risk of device malfunction or failure during deployment. By incorporating patient‐specific information, such as vessel curvature and tortuosity, the simulation tool enables the prediction of potential issues, thus allowing for intervention planning that is tailored to individual anatomy. This patient‐specific approach enhances the safety and efficacy of flow diverter implantation and serves as a foundation for improved device design prior to prototype development.

MAUDE database and Eustachian tube balloon dilation: Evaluation of adverse events and sales data

Study designReview of database. SettingTertiary care neurotology center. PatientsPatients undergoing adverse events. InterventionMAUDE database evaluation of Eustachian tube balloon dilation (ETBD) for the treatment of Eustachian tube dysfunction. Main outcome measuresMedical device reports (MDRs) from the MAUDE database were analyzed for adverse patient events (AE) and device malfunctions (DM) among different devices for ETBD. The objective of this analysis is to assess AE rates and compare them across different devices. Sales data was also used to calculate AE rates. ResultsThere were 18 MDRs noted in the MAUDE database for patients undergoing ETBD out of an initial 23 results. When separated into devices, the Aera had 9 total MDRs (50 %), Xpress had 8 (44.4 %) and Audion had 1 (5.6 %). There were 10 AE and 8 DM. When separated by device, Aera had 4 AEs and 5 DMs, Xpress had 5 AEs and 3 DMs, and Audion had 1 AE. The most common AE was subcutaneous emphysema (n = 4), in the head and neck region with one report of mediastinal involvement. Using this sales data, the Aera balloon has an MDR rate of 0.0128 % is established, with a rate of AE at 0.0058 %. The Audion balloon had an MDR and AE rate of 0.0164 %. ConclusionsETBD is a safe procedure with minimal complications, with subcutaneous emphysema being the most commonly reported adverse event, consistent with literature findings. A comprehensive analysis of AE, coupled with sales data, indicates a commendably low MDR rate of 0.0128 % for the Aera balloon while the Audion balloon had an MDR rate of 0.0164 %. These findings offer valuable insights on post-procedure expectations and engaging in informed consent discussions with patients, highlighting the overall safety of ETBD as an intervention.

Evaluating the Implementation of Automated Malaria Rapid Diagnostic Test Readers in Health Facilities in the Democratic Republic of Congo: Process, Challenges, and Lessons Learned.

The WHO's Global Technical Strategy for malaria emphasizes the importance of reliable malaria surveillance systems to track disease burden and measure progress. A key indicator, the test positivity rate (TPR), largely depends on healthcare providers' adherence to rapid diagnostic test (RDT) results and their accurate reporting. To minimize healthcare providers' bias, this study explored the feasibility of using artificial intelligence (AI)-driven Deki Reader devices in the Democratic Republic of Congo. The devices were deployed in 144 health facilities across Haut Katanga, Kasai Central, and Sud Kivu provinces from January to December 2022. Healthcare providers performed malaria diagnostic tests using RDTs and reported the results through the routine system. In addition, they used the Deki Reader device, which automatically read, recorded, and transmitted the AI interpretation into a cloud database. The study compared TPRs from both sources to identify discrepancies. The study revealed the feasibility of using these devices but also identified several logistic and technical challenges. These included delays in device procurement due to COVID-19 pandemic and customs issues, emphasizing the need for better planning and coordination in future rollouts. Device malfunctions and the reliance on stable internet connectivity highlighted the importance of robust support systems and contingency plans. This study demonstrated both the benefits and challenges of implementing such digital health technologies in primary health facilities. Key considerations for successful deployment include careful planning, adequate training and supervision, and taking into account local infrastructure, especially internet connectivity.

Imputation based wind speed forecasting technique during abrupt changes in short term scenario

AbstractIt is tough and complex to forecast wind speed due to its intermittent and stochastic nature as well as sudden and abrupt variations in the wind speed. Further, it is required to handle the variety of scenarios e.g. cyber‐attacks, unexpected power device malfunction, communication/sensor outages etc. that can cause the missing data.This paper proposes and employs a de‐noising autoencoder algorithm for wind speed forecasting to ensure the handling of missing data information. At the next step, the data is processed via variational mode decomposition technique to mitigate the noise and improves the model's prediction accuracy. Furthermore, the bi‐directional long‐short term memory deep learning approach is tied with convolution neural network to increase prediction accuracy and anticipating the sudden/abrupt changes in wind speed accurately. Finally, actual wind speed related data is examined to scrutinize meticulousness of projected forecast methodology particularly during sudden/abrupt changes in the wind speed. The parameter indicators of the wind speed forecasting technique exhibit the capability of improved predictions under the diversified conditions.

Role of a Home-visit Nursing Agency in Supporting Patients with Heart Failure on Continuous Catecholamine Infusion: A Case Series Study.

This study aimed to discuss the role of home-visit nurses in managing continuous catecholamine infusion in patients with heart failure by investigating the outcome of patients and the home-visit nursing intervention. We conducted a retrospective, case series study of eight patients with heart failure who underwent home-based continuous catecholamine infusion between April 2016 and March 2024. Data including the patients' demographics, the duration of continuous catecholamine infusion, the frequency of nursing and emergency nursing visits, and patients' endpoints were collected. The median age of the patients was 68.5 (interquartile range: 51.8-80.0) years and 75% were men. The most common diagnosis requiring home-based catecholamine infusion was dilated cardiomyopathy. The median duration of continuous catecholamine infusion in the patients was 58.0 days. The median frequency of nursing visits was 8.4 times each week. Forty-five emergency nursing visits occurred, and the most common reason for these visits was managing infusion device malfunctions. Among the patients, six died at home, one was hospitalized owing to fatal arrhythmia, and one withdrew from continuous catecholamine infusion. This study shows the complexities of providing home-based care for patients with heart failure requiring continuous catecholamine infusion. Most patients with heart failure were able to spend the rest of their lives at home, despite the challenges of managing such a treatment outside the hospital. Our findings indicate the need for early intervention, multidisciplinary collaboration, and the development of home care protocols to optimize treatment efficacy and the quality of life of these patients.

Cyber-Securing Medical Devices Using Machine Learning: A Case Study of Pacemaker

This study aims to enhance the cybersecurity framework of pacemaker devices by identifying vulnerabilities and recommending effective strategies. The objectives are to pinpoint cybersecurity weaknesses, utilize machine learning to predict security breaches, and propose countermeasures based on analytical trends. The literature review highlights the transformation of pacemaker technology from basic, fixed-rate devices to sophisticated systems with wireless capabilities, which, while improving patient care, also introduce significant cybersecurity risks. These risks include unauthorized entry, data breaches, and life-threatening device malfunctions. The methodology in this study utilizes a quantitative research approach using the WUSTL-EHMS-2020 dataset, which includes network traffic features, patients' biometric features, and attack label. The step-by-step method of machine learning prediction includes data collection, data preprocessing, feature engineering, and models’ training using Support Vector Machines (SVM) and Gradient Boosting Machines (GBM). The implementation results used evaluation metrics like accuracy, precision, recall, and F1 score to show that GBM model outperformed the SVM model. The GBM model achieved higher accuracy of 95.1% compared to 92.5% for SVM, greater precision of 99.6% compared to 96.7% for SVM, better recall of 94.9% compared to 42.7% for SVM, and a higher F1 score of 76.3% compared to 59.0% for SVM, making GBM model more effective in predicting cybersecurity threats. This study concludes that GBM is an effective machine learning model for enhancing pacemaker cybersecurity by analyzing network traffic and biometric data patterns. Future recommendations for improving the pacemaker cybersecurity include implementing GBM model for threat predictions, integration with existing security measures, and regular model updates and retraining.

Medical Device Malfunction Reporting.

Medical Device Malfunction Reporting.

Adverse Events of the Over The Scope Endoscopic Clips and Cutters: A MAUDE Database Analysis

The OVESCO® clip system, including the Over-The-Scope Clip (OTSC) and Full-Thickness Resection Device (FTRD), has demonstrated efficacy in managing various gastrointestinal pathologies. However, real-world data on device malfunctions and patient complications are limited. This study aimed to analyze adverse events associated with OVESCO® clips and cutters reported to the FDA Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database was searched for reports related to OVESCO® clips and cutters from January 1, 2007, to August 30, 2024. Event date, device type and model, manufacturer, event type, device problem, and patient complications were extracted. Descriptive statistics were used to summarize the findings. Forty-two reports were identified, with 41 involving OVESCO® clips and one involving an OVESCO® cutter. The most common device problem for OVESCO® clips was failure to deploy (61.0%), followed by unintended deployment or misfiring (17.1%). Gastrointestinal perforation was the most frequently reported patient complication (60%). The OVESCO® cutter report described device component breakage and foreign body retention. No clear trends in adverse event reporting were observed over the study period. OVESCO® clips and cutters are associated with potential device malfunctions and patient complications, particularly gastrointestinal perforation. The findings highlight the need for careful patient selection, meticulous technique, and close post-procedural monitoring. Collaborative efforts among stakeholders are essential to optimize device safety and efficacy. Continued post-marketing surveillance and real-world data analysis are crucial for monitoring the performance of endoscopic devices and improving patient outcomes.

Resonance Suppression Method Based on Hybrid Damping Linear Active Disturbance Rejection Control for Multi-Parallel Converters

The parallel operation of multiple LCL-type converters will result in a deviation of the resonant frequency and resonance phenomena. The occurrence of harmonic resonance can cause problems such as an increase in harmonic voltage and current. This can lead to the malfunction of relay protection and automatic devices, causing damage to system equipment. In severe cases, it can cause accidents and threaten the safe operation of the power system. A hybrid damping active disturbance rejection control (HD-ADRC) method is proposed in this paper to suppress the harmonic resonance of parallel LCL-type converters. First, a third-order linear disturbance rejection controller (LADRC) including the linear extended-state observer and the error-feedback control rate is designed based on LCL-type converter model analysis. The proposed method considers the resonance couplings caused by both internal and external disturbances as the total disturbance, thus improving the anti-disturbance capabilities as well as the operational stability of converters in parallel. Then, a hybrid damping control is proposed to reconstruct the damping characteristics of converters to suppress the parallel resonance spike and reduce the resonance frequency offset. And the parameter selection of the control system is optimized through a stability analysis of the tracking performance and anti-disturbance performance of the HD-ADRC controller. Finally, all the theoretical considerations are verified by simulation and experimental results based on the Matlab/Simulink 2018B and dSpace platform. The simulation and experimental results show that the PI controller gives a THD of 5.33%, which is reduced to 4.66% by employing the HD-LADRC, indicating an improved decoupling between the converters working in parallel with the proposed control scheme.

Palliative Radiation Treatment in Patients Managed With Advanced/Interventional Pain Therapy such as Pump-delivered Continuous Opioids.

The study aim was to analyze the feasibility and efficacy of palliative radiotherapy in patients receiving advanced/interventional pain therapy, such as epidural or spinal anesthesia or subcutaneous pump delivery of opioids. Endpoints such as pain relief, treatment in the last month of life and survival were evaluated. Different baseline parameters including but not limited to age and Eastern Cooperative Oncology Group performance status (ECOG PS) were assessed. Outcomes were abstracted from electronic health records. The Edmonton Symptom Assessment System (ESAS) was utilized to score pain intensity. The study included 48 patients, 44 of whom completed radiotherapy as prescribed. Device malfunction was not observed. Overall, 31 patients (65%) had journal notes available allowing for evaluation of pain relief. Twenty-six of 31 experienced pain relief (54% in the intention-to-treat population of 48 study patients). Twelve patients (25%) stopped interventional pain therapy and were converted to transdermal or oral drugs. Median survival was 1.6 months. Forty-four percent had received radiotherapy during the last month of life. Sixty-four percent of patients with ECOG PS 3-4 had received radiotherapy during the last month of life, compared to 22% of those with ECOG PS <3, p=0.004. Palliative radiotherapy was feasible in this setting, but given the short median survival and high likelihood of treatment during the last month of life, patient selection and choice of fractionation regimen should be optimized. The record review identified several patients who experienced worthwhile pain relief, sometimes leading to conversion of pain therapy back to non-invasive oral or transdermal application.

Safety and effectiveness of SOFIA/SOFIA PLUS for direct aspiration as first line treatment in patients with acute anterior ischemic stroke: results from the prospective, multicentric SESAME study.

Mechanical thrombectomy is a cornerstone treatment for acute ischemic stroke (AIS) with large vessel occlusion (LVO), yet the optimal technique remains debated. The SOFIA/SOFIA PLUS catheter has emerged as a promising tool for direct aspiration thrombectomy. This prospective multi-center study, adhering Good-Clinical-Practice guidelines, aimed to evaluate the safety and efficacy of the SOFIA/SOFIA PLUS catheter for direct aspiration as a first-line treatment technique in patients with acute anterior circulation LVO. Between 10/2017 and 12/2021, 246 consecutive patients presenting with AIS due to anterior circulation LVO were enrolled from 14 European centers. Primary treatment with SOFIA catheters was performed within 6 h of symptom onset. Clinical and radiological data were collected, and statistical analyses were conducted. The mean age of the included patients was 71.6 ± 13.9 years, with 44.7% being male. Primary aspiration achieved complete recanalization in 72.8% of patients, with functional independence observed in 63.8% after 90 days. Secondary outcomes included a median NIHSS of 4 at 24 h post-procedure, median ASPECTS of 7 on follow-up imaging, and a mortality rate of 24.4% at 90 days. No device malfunctions were observed, and the rate of symptomatic intracranial hemorrhage was 4.4%. Primary aspiration with the SOFIA/SOFIA PLUS catheter demonstrates favorable safety and efficacy profiles in the treatment of anterior circulation LVO. These findings support the utilization of this technique as a first-line approach in mechanical thrombectomy for AIS, contributing to the growing body of evidence endorsing the effectiveness of direct aspiration thrombectomy in stroke management.

Adverse events related to robotic-assisted knee arthroplasty: a cross-sectional study from the MAUDE database.

Robotic-assisted surgical technique has been clinically available for decades, yet real-world adverse events (AEs) and complications associated with primary knee arthroplasty remain unclear. In March 2023, we searched the FDA website and extracted AEs related to robotic assisted knee arthroplasty (RAKA) from the MAUDE database over the past 10 years. The "Brand Name" function queried major robotic platforms, including active and semi-active systems. The overall incidence of AEs was estimated based on annual surgical volume from the current American Joint Replacement Registry (AJRR). Two authors independently collected data on event date, event type, device problem, and patient problem. Of 839 eligible reports, device malfunction comprised mechanical failure (343/839, 40.88%) and software failure (261/839, 31.11%). For surgical complications, inappropriate bone resection (115/839, 13.71%) was most frequent, followed by bone/soft tissue damage (83/839, 9.89%). Notably, over-resection exceeding 2mm (88/839, 10.49%), joint infection (25/839, 2.98%), and aseptic loosening (1/839, 0.12%) were major complications. Only two track pins related AEs were found. Moreover, the distribution of these AEs differed substantially between robot manufacturers. According to the AEs volume and AJRR data, the overall incidences of AEs related to RAKAs were calculated with 0.83% (839/100,892) between November 2010 and March 2023. Our analysis shows that while reported AEs might be increasing for RAKAs, the overall rate remains relatively low. Reassuringly, device malfunction was the most commonly AEs observed, with a minor impact on postoperative outcomes. Furthermore, our data provide a benchmark for patients, surgeons, and manufacturers to evaluate RAKA performance, though continued improvement in reducing serious AEs incidence is warranted.

Map‐matching for cycling travel data in urban area

AbstractTo promote urban sustainability, many cities are adopting bicycle‐friendly policies, leveraging GPS trajectories as a vital data source. However, the inherent errors in GPS data necessitate a critical preprocessing step known as map‐matching. Due to GPS device malfunction, road network ambiguity for cyclists, and inaccuracies in publicly accessible streetmaps, existing map‐matching methods face challenges in accurately selecting the best‐mapped route. In urban settings, these challenges are exacerbated by high buildings, which tend to attenuate GPS accuracy, and by the increased complexity of the road network. To resolve this issue, this work introduces a map‐matching method tailored for cycling travel data in urban areas. The approach introduces two main innovations: a reliable classification of road availability for cyclists, with a particular focus on the main road network, and an extended multi‐objective map‐matching scoring system. This system integrates penalty, geometric, topology, and temporal scores to optimize the selection of mapped road segments, collectively forming a complete route. Rotterdam, the second‐largest city in the Netherlands, is selected as the case study city, and real‐world data is used for method implementation and evaluation. Hundred trajectories were manually labelled to assess the model performance and its sensitivity to parameter settings, GPS sampling interval, and travel time. The method is able to unveil variations in cyclist travel behavior, providing municipalities with insights to optimize cycling infrastructure and improve traffic management, such as by identifying high‐traffic areas for targeted infrastructure upgrades and optimizing traffic light settings based on cyclist waiting times.

Intragastric balloon adverse events: a comprehensive MAUDE database review

Background Endoscopic bariatric interventions are viable alternatives to traditional weight loss surgeries for patients with a body mass index between 30 and 40 kg/m2. While studies have explored the impact of intragastric balloons on obesity and weight reduction, comprehensive data on real-world device-related complications and failures are limited. This study aimed to investigate mechanical failures leading to patient adverse events reported to the US Food and Drug Administration. Methods A retrospective analysis using the Manufacturer and User Facility Device Experience (MAUDE) database examined device-related events and patient outcomes associated with various intragastric balloons from July 2017 to October 2023. Data analysis was performed using SPSS software to assess the reported events and their associations with specific types of intragastric balloons. Results Our review included 1393 cases, revealing 1758 device malfunctions and 1760 patient complications. Deflation problems (25.31%) and balloon leakage or rupture (21.90%) were the most common device-related complications. Patient complications were primarily linked to the Orbera balloon, with implant failure (24.30%), abdominal pain (21.92%), and vomiting (21.26%) as leading adverse events. Conclusion Our findings highlight the need for continuous surveillance, rigorous monitoring, and enhanced safety protocols for intragastric balloons.

Impella 5.5: A Systematic Review of the Current Literature.

Impella 5.5 (Abiomed, Danvers, MA, USA) is a temporary mechanical circulatory support device used for patients in cardiogenic shock. This review provides a comprehensive overview of the device's clinical effectiveness, safety profile, patient outcomes, and relevant procedural considerations. We conducted a systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines using the PubMed/MEDLINE database. The search query included articles available from October 6, 2022, through January 13, 2023. Our initial search identified 75 studies. All records were screened by 2 independent reviewers using the Covidence software for adherence to our inclusion criteria, and 8 retrospective cohort studies were identified as appropriate for inclusion. Across the included studies, the sample size ranged from 4 to 275, with predominantly male cohorts. Indications for Impella support varied, and the duration of support ranged from 9.8 to 70 days. Overall, Impella support appeared to be associated with favorable survival rates and manageable complications in various patient populations. Complications associated with Impella use included bleeding, stroke, and device malfunctions. Two studies compared prolonged and Food and Drug Administration-approved Impella support, showing similar outcomes and adverse events. Impella 5.5 continues to be an attractive option for bridging patients to definitive therapy. Survival during and after Impella 5.5 was favorable for patients regardless of initial indication. However, device use was associated with several important complications, which calls for judicious use and a precontemplated exit strategy. Limitations of this literature review include biases inherent to the retrospective studies included, such as selection and publication bias.

Performance and safety of volume guarantee ventilation in neonates using the fabian ventilator, a multicenter study.

To evaluate the performance (i.e., agreement between set and measured parameters) and safety (adverse events, device malfunctions, and ventilator alarms) of the fabian HFOi neonatal ventilator in volume guaranteed (VG) mode during conventional ventilation. To analyze the impact of leakage around the endotracheal tube and the set maximum allowed inflating pressure (Pmax). Prospective multicenter observational study. Clinical and ventilator data were collected from 71 infants receiving VG ventilation for ≥12 h in four neonatal intensive care units (NICUs). Ventilator settings, parameters, and alarms were downloaded with 0.5 Hz sampling rate. Data from 4,341 h of ventilation were analyzed. The median (interquartile range, IQR) of the absolute difference between the target and measured expired tidal volume was 0.76 (0.51-1.16) mL/kg. It was less when leak was <50% (median 0.36, IQR: 0.25-0.64 mL/kg, p < .001) and even less when the required peak inflating pressure (PIP) was also below Pmax (median: 0.09 mL/kg, IQR: 0.00-0.16 mL/kg, p < .001). On NICUs setting Pmax higher, tidal volume was maintained significantly closer to target. In 56 patients VG was continued until extubation. Two ventilator malfunctions were reported, none of them resulting in patient harm. "Tidal volume not reached" alarm occurred 32 times hourly, usually lasting for <10 s. The fabian HFOi ventilator maintains tidal volume close to its target, particularly when leak is <50% and when PIP is below Pmax. In most patients VG can be continued until extubation. Despite frequent ventilator alarms, ventilator malfunctions occur very rarely.

Polydopamine‐coated iron‐nickel alloy and epoxy composites for electromagnetic interference shielding

AbstractWith the development of electronic devices and wireless communication technology, the quality of human life has improved. However, shielding from electromagnetic interference (EMI) is required due to device malfunctions and harmful effects on human health. Polymer‐based shielding materials getting much attention due to their light weight, flexibility, good processability, and other desirable traits. However, achieving consistent dispersion of conductive fillers and optimizing the balance between electrical, mechanical, and thermal properties remain challenges despite the advantages of polymer‐based materials. Especially, epoxy resins are promising polymer materials for EMI shielding applications due to their excellent mechanical strength, chemical resistance, and excellent adhesive properties. Additionally, epoxy resin exhibits remarkable processability allowing for various fabrication techniques such as casting, molding, and three‐dimensional printing. However, one of the significant drawbacks of epoxy resin is the difficulty in achieving uniform dispersion of conductive fillers within the epoxy matrix. In this study, we propose an iron‐nickel alloy (FeNi) embedded in an epoxy matrix (FeNi/Epoxy) for EMI shielding material. It is manufactured by facile fabrication process due to the advantages of epoxy, which has excellent processability. EMI shielding effectiveness at 12 GHz is enhanced from 9.12 to 17.86 dB by the increase of FeNi concentrations. Furthermore, thermal and mechanical properties were improved by the increase of FeNi concentration. Thermal conductivity for efficient heat dissipation is increased from 0.63 to 1.49 Wm−1 K−1. Moreover, polydopamine (PDA) was employed as a surface coating material for FeNi to overcome the non‐uniform dispersion of FeNi particles in the epoxy matrix. Surface coating by PDA significantly enhanced the dispersion uniformity and strengthened the adhesion between the filler and matrix. Elastic modulus is greatly increased from 83.03 MPa to 1.29 GPa by the surface coating. The enhancement of mechanical properties is derived from the chemical bonds between the filler and matrix.