Manufacturing Facility Research Articles

Underreporting of complications following AF ablation: Comparison of the manufacturer and user facility device experience FDA database and a voluntary invitation-based registry: The POTTER-AF 3 study

BackgroundThe Manufacturer and User Facility Device Experience (MAUDE) database houses medical device reports of adverse events involving medical devices marketed in the United States submitted to the U.S. Food and Drug Administration (FDA) by mandatory and voluntary reporters. The MAUDE database is frequently used in clinical studies to report on device-related complications. Data about its efficacy are scarce. ObjectiveWe aimed to compare the mandatory MAUDE database (MAUDE group) with the invitation-based POTTER-AF study (POTTER-AF 1 group) regarding data quality, procedural characteristics, diagnosis, treatment, and survival. MethodsThe reports of esophageal fistula esophageal fistula following atrial fibrillation (AF) ablation in the MAUDE database were compared with those in the POTTER-AF study between August 1, 2009, and August 31, 2019. ResultsEsophageal fistulas were reported in 47 patients in the MAUDE group and in 81 in the POTTER-AF 1 group. Procedures were performed with radiofrequency, cryoenergy, or laser energy in 66.0%, 31.9%, and 2.1% (MAUDE group) and in 96.3%, 2.5%, and 1.2% (POTTER-AF 1 group). The median time to symptoms was 21 (14, 32.5) days (MAUDE group) and 18.0 (6.8, 22.3) days (POTTER-AF 1 group; P = .031). The diagnostic method was reported in 38.3% of patients in the MAUDE group and in 98.8% in the POTTER-AF 1 group, the treatment in 57.4% and 100%, and the outcome in all patients. In the MAUDE group, treatment was surgical (51.9%), endoscopic (37.0%), combined (3.7%), or conservative (7.4%), compared with 43.2%, 19.8%, 7.4%, and 29.6% in the POTTER-AF 1 group. Overall mortality was 76.6% in the MAUDE group and 61.7% in the POTTER-AF 1 group (P = .118). ConclusionIn the mandatory MAUDE database, fewer esophageal fistula cases were reported compared with an invitation-based study. The data quality in the MAUDE database was significantly poorer.

Instrument failures for the AirSeal device: A Food and Drug Administration MAUDE database study

ObjectiveThis study aims to analyze instances of AirSeal device failures reported in the Food and Drug Administration's MAUDE (Manufacturer and User Facility Device) database, focusing on identifying trends in failure types and locations. Summary Background DataThe AirSeal device has revolutionized minimally invasive surgery by providing stable pneumoperitoneum and optimal visualization. However, concerns about its reliability and safety have surfaced. MethodsRetrospective analysis of the MAUDE database. A search for ‘AirSeal’ device-related events from 2014 to 2023. A total of 411 events resulting in injury, death, or other complications were identified, and data were extracted from these reports. Data extraction included report number, event date, event type, manufacturer, patient problem, and number of events. It should be noted that detailed information such as the specific organs involved or the exact surgical procedures were not available in the MAUDE database reports. ResultsOver the 9-year period, 411 AirSeal device-related events were reported in MAUDE. The predominant failure mechanisms included device breakage 266 (64.7%), defective failures 16 (3.9%), flow failures 13 (3.2%), leak failures 8 (1.9%), patient-device interaction issues 5 (1.2%), and pressure-related failures 4 (1.0%). Among the reports, incidents related to the valveless-trocar included 261 (63.5%), whereas the insufflator was implicated in 150 reports (36.5%). The most common event reported involving the patient was embolism listed in 35 cases. There is also an increase in the number of cases reported annually. ConclusionFurther research is warranted to understand the root cause of device failure and implement targeted interventions aimed at mitigating any risks associated with the AirSeal device. Ultimately, collective efforts are directed towards upholding the highest standards of patient safety in this era of minimally invasive surgery.

The Effect of Professional Social Norms on Corporate Environmental Compliance

While previous studies demonstrate the importance of social norms for explaining the pro-environmental behavior of individual consumers, very few studies examine the role of social norms in the context of businesses’ pro-environmental decisions. This study contributes to the rich social norm literature by exploring whether professional social norms influence the compliance decisions of regulated chemical manufacturing facilities. To this end, the empirical analysis uses data on major facilities regulated under the U.S. Clean Water Act to estimate the link from the compliance history of other major chemical manufacturing facilities operating in the same state to an individual facility’s current compliance decision. Using a fixed-effects model that includes a large set of confounding factors, we find a significant positive effect of other facilities’ compliance history: improvement in the average compliance history prompts the individual facility to increase its own performance. By controlling for other plausible channels that link facility’s compliance decisions, we interpret this relationship as reflecting descriptive professional norms. The relationship proves stronger for facilities that are either geographically or sectorally closer.

Facile manufacturing of carbon nanotube/ZIF-67-derived cobalt composite aerogel with high-efficiency electromagnetic wave absorption

Developing high-efficiency electromagnetic wave (EMW) absorbers by designing dielectric/magnetic components and microstructure in a straightforward, scalable method is highly desirable yet challenging. Here, we introduce a novel hierarchical composite aerogel-based EMW absorber composed of conductive carbon nanotubes (CNTs) and magnetic metal-organic framework (MOF) derivatives, integrated with sustainable cellulose nanofibers (CNF) derived carbon. This composite was prepared using a scalable freeze-casting followed by carbonization approach. Freeze casting enabled the creation of porous monoliths with high specific surface areas and customizable pore sizes and porosities, crucial for enhancing EMW reflection and scattering. Carbonization enhanced composite conductivity and stabilized the cobalt (Co)/carbon nanoparticles derived from ZIF-67 within the carbon matrix. CNF-derived carbon facilitated the efficient integration of ZIF-derived Co nanoparticles and CNTs, resulting in a robust 3D aerogel structure. The synergistic effects of CNT conductive paths and Co nanoparticles' magnetic losses provided an efficient route to enhance EMW absorption. Moreover, the creation of numerous heterogeneous interfaces augmented polarization losses, significantly enhancing EMW loss capability. Remarkably, the composite achieved outstanding EMW absorption, with a minimum reflection loss of -71.03 dB at a filling ratio of merely 10 wt.% and an effective absorption bandwidth of 4.64 GHz, comparable to leading EMW absorbers reported to date.

LncRNA 51A: A promising diagnostic biomarker for assessing cognitive decline in occupationally exposed aluminum workers

ObjectiveTo assess the diagnostic utility of lncRNA 51 A in detecting cognitive decline among aluminum-exposed workers occupationally. Methods921 male workers from an aluminum manufacturing facility underwent cognitive assessments, measurement of plasma aluminum levels and quantification of lncRNA 51 A levels. Receiver Operating Characteristic (ROC) curves were constructed to assess the diagnostic potential of lncRNA 51 A. Bayesian network model was utilized to predict the likelihood of cognitive decline among the study population. ResultsSignificant differences in lncRNA 51 A levels, plasma aluminum concentration and MMSE scores were observed between cognitive normal and decline groups. The lncRNA 51 A expression was negatively correlated with MMSE scores. The area under the curve (AUC) was 0.894, with 89.3 % sensitivity and 73.9 % specificity. The Bayesian network model indicated varying probabilities of cognitive decline based on lncRNA 51 A expression levels. ConclusionPlasma lncRNA 51 A shows potential as an excellent biomarker for cognitive decline diagnosis in aluminum-exposed workers.

A stable method for task priority adaptation in quadratic programming via reinforcement learning

In emerging manufacturing facilities, robots must enhance their flexibility. They are expected to perform complex jobs, showing different behaviors on the need, all within unstructured environments, and without requiring reprogramming or setup adjustments. To address this challenge, we introduce the A3CQP, a non-strict hierarchical Quadratic Programming (QP) controller. It seamlessly combines both motion and interaction functionalities, with priorities dynamically and autonomously adapted through a Reinforcement Learning-based adaptation module. This module utilizes the Asynchronous Advantage Actor–Critic algorithm (A3C) to ensure rapid convergence and stable training within continuous action and observation spaces. The experimental validation, involving a collaborative peg-in-hole assembly and the polishing of a wooden plate, demonstrates the effectiveness of the proposed solution in terms of its automatic adaptability, responsiveness, flexibility, and safety.

Contribution to the implementation of ISO 22000:2018 within the NOUNOURS agri-food company: case study of a NOUNOURS manufacturing facility

Contribution to the implementation of ISO 22000:2018 within the NOUNOURS agri-food company: case study of a NOUNOURS manufacturing facility

A Comparative Study between Theoretical and Measured Performance of Standard Centrifugal Pumps Running as Turbines

High cost of custom-made conventional turbines and the lack of local manufacturing facilities have created significant obstacles to the development of Pico/micro hydroelectric schemes in the country. In this context it has been identified pump as turbine (PAT) electric schemes can have distinct advantages over conventional turbines because pumps are manufactured locally at mass scale and available in various sizes. But not all pumps are suitable for use as PAT because they have different design details and manufacturing qualities. The performance of a pump used as a turbine is assessed based on two primary parameters: turbine mode head and flow at the Best Efficiency Point (BEP). There are various methods available in the literature for predicting PAT theoretical head and flow at BEP. These methods aim to estimate how the pump will perform when used as a turbine. Despite these prediction methods, there is a consistent deviation of approximately ±20% between the theoretical estimates and the actual measured performance. This indicates that real-world conditions and factors not accounted for in theoretical models can significantly affect the performance of PAT systems. The primary objective of the present study was to measure the deviation between the actual performance and the predicted performance of two PAT systems in terms of head and flow at BEP. This deviation was then compared to the commonly mentioned figure of ±20% in the literature. The study focused on using what it considered to be the most accurate prediction method among those presented in the literature to estimate PAT head and flow at BEP and involved running reverse, 1.1 kW, and 1.6 kW direct-drive standard centrifugal type water pumps in a test rig to measure the actual performance of the two PATs. The results of the study showed a deviation of +27% and -22% between the actual measured head and flow at BEP, and the values predicted by the theoretical method. This deviation is slightly outside the commonly mentioned range of ±20% found in the literature, but this is not expected to have a detrimental effect on the generation of electric power. This implies that, even with the observed slight deviation, the prediction method used in this study can be satisfactorily employed to estimate PAT head and flow at BEP.

Unveiling the mix-up: investigating species and unauthorized tissues in beef-based meat products

Customers are very concerned about high-quality products whose provenance is healthy. The identification of meat authenticity is a subject of growing concern for a variety of reasons, including religious, economic, legal, and public health. Between March and April of 2023, 150 distinct marketable beef product samples from various retailers in El-Fayoum, Egypt, were gathered. There were 30 samples of each of the following: luncheon, kofta, sausage, burger, and minced meat. Every sample underwent a histological investigation as well as subjected to a standard polymerase chain reaction (PCR) analysis to identify meat types that had not been stated by Egyptian regulations. According to the obtained data, the meat products under scrutiny contained a variety of unauthorized tissues which do not match Egyptian regulations. Furthermore, the PCR results indicated that the chicken, camels, donkeys, and pigs derivatives were detected in 60%, 30%, 16%, and 8% of examined samples, respectively. In conclusion, besides displaying a variety of illegal tissues, the majority of the meat items under examination were tainted with flesh from many species. As a result, it is crucial to regularly inspect these products before they are put on the market to ensure that they comply with the law and don’t mislead customers Furthermore, it is advisable for authorities to implement rigorous oversight of food manufacturing facilities to ensure the production of safe and wholesome meat.

Appraising sustainability and economic growth through Fintech, green finance and natural resource in Asian economies: A CS-ARDL study

Governments in Asian economies are under immense pressure from an ecological perspective and are trying to increase compliance with environmental policies by institutions and households, which have the objective of reducing environmental pollution. This is because the Asian region contributes two-thirds of the global growth. However, because of the conventional manufacturing facilities and infrastructure, the Asian region had to rely on the consumption of the Natural Resource (NTR) for their economic development; thus,the environment is being harshly affected, eventually affecting the quality of life of every dweller. Therefore, this research revisits the Asian economies due to their global significance in financial, environmental and sustainable development. Moreover, the present study evaluates the role of Fintech (FNT), Green Finance (GFN) and Natural Resource (NTR), in diluting the disparity betweeneconomic and ecological sustainability. The current study explores these relationships through the help of an advanced and recent estimation technique named “Cross-section augmented autoregressive distributed lags (CS-ARDL)”. Through the generated outcome from CS-ARDL, FNT, NTR, and GFN are found to support the Economic Growth (ECG). From the environmental perspective, the role of FNT and GFN was found to be satisfying as they lead to reduced environmental pollution. However, the role of NTR was found to destroy ecological health, which is the validation of the earlier studies but does require careful attention from the concerned authorities. In light of these findings, the Asian governments will be in a better position to identify, devise and select appropriate strategies and policies that will assist in alleviating environmental pollution and strengthening economic development.

A highly responsive and sensitive flexible strain sensor with conductive cross-linked network by laser direct writing

As a critical component of wearable electronic devices, flexible strain sensors have made significant contributions in the fields of smart healthcare, motion monitoring and communication, garnering escalating research interests. However, the pursuit of ideal materials synergizing high sensitivity with facile and cost-effective manufacturing methodologies remains a persistent challenge, significantly hindering the full realization of the potential of flexible strain sensors. Herein, an innovative hybrid conductive network architecture constituted by multi-walled carbon nanotubes and laser-induced graphene (MWCNTs/LIG) has been explored via a facile, cost-effective, controllable, and environmentally friendly laser direct writing (LDW) technique. Subsequently, the resultant MWCNTs/LIG composite with a cross-linked microstructure has been harnessed for the fabrication of a high-performance strain sensor. Notably, the proposed sensor exhibits remarkable sensitivity with a gauge factor (GF) reaching 192, rapid response and recovery times of 27/20 ms, and favorable durability exceeding 2300 cycles. Furthermore, the developed sensor demonstrates the capability to accurately capture full-range motions in real-time, as well as the ability to transmit information as a portable communication device. This promising discovery offers a new insight for the flourishing development of high-performance flexible strain sensors in the realm of wearable sensing.

A Waste Heat Assessment of a Manufacturing Facility With Consideration for Demand Matching Through Thermal Energy Storage

Abstract A waste heat assessment of a manufacturing facility was conducted. A physical survey identified potential waste heat sources. For these sources, the temporal fluctuations in temperature and flowrate, and the frequency of occurrence of the waste heat, were determined from measurements, calculations, and company records. The energy and exergy of the waste heat were calculated. The total annual waste heat is 36.5 TJ of energy, which represents 0.84 TJ of exergy. The boiler, plant vacuums, and chiller comprise 96% of the energy rejected and are the major contributors to the rejected exergy. Using the waste heat for space heating is evaluated. Based on fuel consumption in the boiler, the annual energy for space heating is estimated at 8.5 TJ. Theoretically, waste heat from the boiler flue, polypropylene dryers, and plant vacuums could meet up to 39% of this energy without storage. Simply allowing the vacuum exhausts to cool in the building could theoretically meet up to 27%. Models are developed to investigate using waste heat recovery and thermal energy storage (TES) to provide space heating for a prototype warehouse building, and estimates for the initial costs of the recovery system are developed. Modeling indicates that TES is highly beneficial for matching short-term demand fluctuations and for smoothing the temporal oscillations in the waste heat. A nine-month heating season is simulated to determine the fraction of the load met by the recovery system. A small amount of thermal storage, e.g., 12.5–25% of daily waste heat, improved the fraction of demand that could be met. Larger sizes had diminishing returns and significantly increased the initial cost and payback period. To reduce initial cost, a refined recovery system design that uses a TES as an intermediate and for storage is proposed. The study highlights the need to consider fluctuations in the waste heat supply and sink demand, for thermal storage, and to identify relatively simple modifications to recover waste heat.

An in-situ hybrid laser-induced integrated sensor system with antioxidative copper

Integration of sensors with engineering thermoplastics allows to track their health and surrounding stimuli. As one of vital backbones to construct sensor systems, copper (Cu) is highly conductive and cost-effective, yet tends to easily oxidize during and after processing. Herein, an in-situ integrated sensor system on engineering thermoplastics via hybrid laser direct writing is proposed, which primarily consists of laser-passivated functional Cu interconnects and laser-induced carbon-based sensors. Through a one-step photothermal treatment, the resulting functional Cu interconnects after reductive sintering and passivation are capable of resisting long-term oxidation failure at high temperatures (up to 170 °C) without additional encapsulations. Interfacing with signal processing units, such an all-in-one system is applied for long-term and real-time temperature monitoring. This integrated sensor system with facile laser manufacturing strategies holds potentials for health monitoring and fault diagnosis of advanced equipment such as aircrafts, automobiles, high-speed trains, and medical devices.

Prenatal developmental toxicity studies of allyl alcohol in rats and rabbits

Allyl alcohol (C3H6O; prop-2-en-1-ol; CAS RN 107-18-6; EINECS 203-470-7) is used as an intermediate/monomer in polymerization reactions producing chemicals/optical resins or as a coupling/cross-linking agent for unsaturated polyester and alkyd resins. Human exposure to allyl alcohol (AA) is restricted to workplace manufacturing facilities where it is used in enclosed systems, which limits release and impact on environmental receptors. To address regulatory questions about possible developmental toxicity, two OECD Guideline studies were conducted. A rat developmental toxicity study found fetal and maternal toxicity, in the form of resorptions and decreased body weight and food consumption, but no teratogenic effects. A rabbit developmental toxicity study was subsequently conducted upon request by the European Chemical Agency in 2011 under the REACH program and likewise reported maternal toxicity in the form of reductions in body weight gain and food consumption, but neither fetal toxicity or teratogenic effects. The results of both studies are presented and compared in this paper. Based on our review of the collective results of these studies, AA is considered non-teratogenic, yet does elicit increased post-implantation loss and reduced fetal body weight, possibly resulting from concomitant maternal toxicity. Based on the results of these studies, a maternal and developmental toxicity No Observed Adverse Effect Level of 10 mg/kg/day was apparent for both species.

Air Quality Matters: A Holistic Strategy and Approach to HVAC System Validation in Pharmaceuticals

Heating, ventilation, and air conditioning (HVAC) systems plays a critical role in pharmaceutical manufacturing facilities by ensuring the integrity of product quality, safety, and compliance with regulatory requirements. HVAC validation is an essential process that verifies and documents the performance and effectiveness of these systems. This review paper explores various strategies and approaches to HVAC validation in pharmaceutical manufacturing facilities, including regulatory considerations, validation methodologies, risk assessment, and ongoing monitoring. The paper also discusses the challenges associated with HVAC validation and presents best practices to improve the effectiveness of the validation process.

Multidisciplinary cancer disease classification using adaptive FL in healthcare industry 5.0

Emerging Industry 5.0 designs promote artificial intelligence services and data-driven applications across multiple places with varying ownership that need special data protection and privacy considerations to prevent the disclosure of private information to outsiders. Due to this, federated learning offers a method for improving machine-learning models without accessing the train data at a single manufacturing facility. We provide a self-adaptive framework for federated machine learning of healthcare intelligent systems in this research. Our method takes into account the participating parties at various levels of healthcare ecosystem abstraction. Each hospital trains its local model internally in a self-adaptive style and transmits it to the centralized server for universal model optimization and communication cycle reduction. To represent a multi-task optimization issue, we split the dataset into as many subsets as devices. Each device selects the most advantageous subset for every local iteration of the model. On a training dataset, our initial study demonstrates the algorithm's ability to converge various hospital and device counts. By merging a federated machine-learning approach with advanced deep machine-learning models, we can simply and accurately predict multidisciplinary cancer diseases in the human body. Furthermore, in the smart healthcare industry 5.0, the results of federated machine learning approaches are used to validate multidisciplinary cancer disease prediction. The proposed adaptive federated machine learning methodology achieved 90.0%, while the conventional federated learning approach achieved 87.30%, both of which were higher than the previous state-of-the-art methodologies for cancer disease prediction in the smart healthcare industry 5.0.

Research and Development Practices within PEM Water Electrolyzer Manufacturing to Support a Circular Economy

Nel Hydrogen has in the last decades substantially invested in R&D efforts to consolidate next-generation PEM stacks and systems towards a commercial pathway for these devices at scale. These innovative tasks have allowed the company to reach much lower values for levelized costs of hydrogen (LCOHs) supported by devices that are much more efficient and lower costs; but that still holds robustness and long-life characteristics. However, to truly represent a sustainable pathway, the production lifecycle needs to be considered, especially related to critical materials such as catalysts and polyfluorinated alkyl substances (PFAS) used for instance in the membranes. PFAS are beginning to be regulated globally, with a goal of for responsible manufacturing and hence zero disposal to the environment. Recycling programs for the polymers used in electrolyzers can assist in keeping them exempt from PFAS regulations, due to the minimized environmental impact and lack of related emissions. In addition, PEM electrolyzers use a significant amount of platinum group metals (PGMs), including iridium, one of the scarcest naturally occurring elements. Addressing these issues through recycling and a healthy circular economy of these key components is an important part of large-scale commercialization and deployment.Recent customers have already raised questions about supplier philosophy and documentation of environmental practices. In other words, these large-scale market players are looking for instance to be ISO14001 certified; designed to minimize a company’s negative impact on the environment. While recycling of any chemicals is not specifically required by ISO14001, the standards include lifecycle assessments, integration of environmental aspects into product design, reduction of greenhouse gas emissions, and related topics where recycling would have positive impact on the metrics.At the last 244th ECS meeting in Gothenburg 2023, we have shown how recycling (or PGM thrifting) is ultimately required to meet the IEA projected capacity demands for electrolyzers by 2050, or around 2500 GW globally. Our analysis has demonstrated that above 40% market share can be reached by 2050 for PEM electrolysis, proven that: 1)20% annual Iridium production (ca. 8 tons/year) is allocated for PEM electrolyzer manufacturing; 2) significant PGM thrifting (above 80%) is demonstrated for these devices; 3) life-time and robustness of these new low loading electrodes are maintained; and 4) a circular economy (responsible recycling) is stablished. Repurposing other components such as titanium, stainless steel, and fluoropolymers provides some additional value stream from reclamation as well. For maximum benefit, material collection methods need to be set up within the manufacturing facility, to capture waste materials and scrap, as well as through the field population, so that systems no longer being operated can be reclaimed for materials. This talk will cover some of the business considerations for effective recycling, as well as current practices.

Adverse events associated with robotic-assistance in total hip arthroplasty: an analysis based on the FDA MAUDE database.

The Food and Drug Administration (FDA) maintains the Manufacturer and User Facility Device Experience (MAUDE) database for reporting adverse events associated with medical devices, including emerging technologies, such as robotic-assisted total hip arthroplasty (THA). Aim of this study was to evaluate the variation of adverse events associated with robotics in THA. Medical device reports (MDRs) within the MAUDE database were identified between 2017 and 2021. For MDR identification the product class "orthopaedic stereotaxic equipment" and terms associated with THA were used. Individual adverse events were identified and organised by type and consequences, such as patient injury, surgical delay, or conversion to the manual technique. 521 MDRs constituting 546 discrete events were found. The most common reported complication was intraoperative hardware failure (304/546, 55.7%), among which the most common failure was a broken impaction handle/platform (110, 20.1%). Inaccurate cup placement was the second most common reported complication (63, 11.5%). Abandoning the robot occurred in 13.0% (71/521) of reports. A surgical delay was noted in 28% (146/521) of reports, with an average delay of 17.9 (range 1-60) minutes. Identifying complications that may occur with robotics in THA is an important first step in preventing adverse events and surgical delays. Database analysis provide an overview of the range of complications.

The Effect Of Internal Environmental Management On The Performance Of Cement Companies In Indonesia With Mediation Green Supply Chain Management Practices

The global challenge of preserving the environment, meeting demand, and ensuring corporate sustainability drives the cement industry to implement strategies in its supply chain. The practice of green supply chain management is one of the strategies that are well applied in the face of the challenges to the cement industry. Through the GSCM practical dimension consisting of green manufacturing, green purchasing, green transportation, and green facilities, this research will test the impact of the application of GSCM on the performance of cement companies in Indonesia. The thesis used primary data and obtained 224 respondents from 13 groups of cement companies that are part of the Indonesian Cement Association (ASI). The data were analyzed through descriptive statistics and partial least squares (PLS) techniques using smartPLS software version 3.2.9. Research results show that internal environmental management influences GSCM practices and influences the performance of cement companies in Indonesia. Green purchasing only has a positive impact on operational performance and has no impact on the environmental, economic, or social performance of the company. Green transportation is positive for the economic, operational, and social performances of the enterprise but does not have an impact on environmental performance. The study also found that green supply chain management practices strengthen the relationship between internal environmental management and the performance of cement companies in Indonesia.

Failure to treat ventricular tachycardia or ventricular fibrillation by implantable cardioverter-defibrillators

BackgroundNormally functioning implantable cardioverter-defibrillators (ICDs) with intact lead systems occasionally fail to deliver therapy for ventricular tachycardia/fibrillation (VT/VF) or deliver it only after clinically significant delays (failure-to-treat). ObjectiveWe aimed to investigate ICD failure-to-treat VT/VF in a large patient cohort. MethodsWe searched the US Food and Drug Administration's online Manufacturer and User Facility Device Experience (MAUDE) database from 2019 to 2023 for manufacturer-verified reports in which normally functioning ICDs failed to treat VT/VF. ResultsWe identified 854 reports classified as deaths (n = 96 [11.2%]), injuries (n = 585 [68.5%]), or malfunctions (n = 173 [20.4%]) for normally functioning ICDs. The most common causes were misclassification as supraventricular tachycardia (SVT) or atrial fibrillation (AF; 54.8%), undersensing (21.1%), and failure to satisfy programmed rate/duration criteria (8.7%). Most events caused by misclassification as SVT/AF (89.5%) and failure to satisfy rate/duration criteria (70.3%) were VT; most caused by undersensing were either VF (54.4%) or not specified as VT or VF (19.4%). Undersensing caused 65.6% of deaths, although it represented only 21.1% of reports. In the United States, the number of reports increased faster than that of ICD patients. ConclusionIn the largest reported series of failure-to-treat VT/VF by normally functioning ICDs, the most common cause was misclassification of VT as SVT/AF; the most common cause of death was undersensing of VF. Although relatively few patients with normally functioning ICDs experience failure-to-treat VT/VF, the absolute number of verified MAUDE reports suggests that more work is needed to quantify the magnitude of the problem, to identify root causes, and to develop solutions.