PO-02-227 ADVERSE EVENTS ASSOCIATED WITH AUTOMATIC EXTERNAL DEFIBRILLATOR - LIFEPAK: A STUDY FROM FOOD AND DRUG ADMINISTRATION MAUDE DATABASE

Abstract

Automatic External defibrillator (AED) can analyze heart rhythms and allows operators to deliver treatment in patients with tachyarrhythmias or cardiac arrest with a shockable rhythm. The incidence of adverse events (AE) between different ED models is not well known. We sought to assess the type of AE associated with the AED – Lifepak series (Stryker, Kalamazoo, MI) using the FDA Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database is a repository of industry and patient/physician-reported medical device adverse events. A MAUDE database search was conducted on November 10, 2022, for reports received between January 1992 to October 2022 to capture all AE. A total of 32,557 AE were reported from 1992 to 2022. An increase in trends of AE was observed from 1992 to 2022 (0.1% to 7.3%), respectively. Among the 7 Lifepak models, Lifepak CR Plus (5.5%, 1177 events), Lifepak CR2 (5.7%, 1230 events), and Lifepak 20e (5.85%, 1260 events) had the three lowest reported AE while the Lifepak 15 (28.2%, 6073 events), Lifepak 20 (21.2%, 4561 events) and Lifepak 12 (23.6%, 5085 events) had the three highest reported AE (21,503 events). The most commonly reported AE was product malfunction (95.9%, 31,209 events) resulting in patient injury (0.9%, 289 events) and patient death (2.9%, 950 events). Correct utilization of AED is crucial during advanced cardiac life support. Appropriate selection of AED models with clinical situations and operators’ experience is essential.