ANALYSIS OF AUTOMATED EXTERNAL DEFIBRILLATOR FAILURES IN THR FDA MAUDE DATABASE

Abstract

Sudden cardiac arrest (SCA) is a leading cause of death worldwide. It is estimated that more than 3 million people die yearly. Early defibrillation using the automated external defibrillator (AED) has a key role in restoring normal heartbeat of a cardiac arrest patient. AED malfunction can convert the device from a life-saving to a life threatening device. According to FDA, automated external defibrillators (AEDs) are classified as Class-III high-risk medical devices. According to the FDA adverse event database, batteries are the most failure-prone AED components. Good estimation of AED battery life can help avoid AED adverse events, improve AED device reliability, and determine the minimum acceptable warranty period. Having a good battery management plan including a reasonable replacement time and a sufficient warranty period can easily lead to determine safely when the battery end-of-life is.