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Title:Analysis of Safety-Critical Computer Failures in Medical Devices
Author(s):Alemzadeh, Homa; Iyer, Ravishankar K.; Kalbarczyk, Zbigniew; Raman, Jai
Subject(s):Medical devices
Failure analysis
FDA recalls
FDA adverse events
Abstract:Incidents due to malfunctioning medical devices are a major cause of serious injury and death in the United States. During 2006–2011, 5,294 recalls and around 1.2 million adverse events were reported to the U.S. Food and Drug Administration (FDA). Almost 23% of these recalls were due to computer-related failures, of which around 94% presented medium-to-high risk of severe health consequences (such as serious injury or death) to patients. This paper investigates the causes of failures in computer-based medical devices and their impact on patients, by analyzing human-written descriptions of recalls and adverse event reports, obtained from public FDA databases. We characterize computer-related failures by deriving fault classes, failure modes, recovery actions, and number of devices affected by the recalls. This analysis is used as a basis for identifying safety issues in life-critical medical devices and providing insights on the future challenges in the design of safety-critical medical devices.
Issue Date:2013-03
Publisher:Coordinated Science Laboratory. University of Illinois at Urbana-Champaign.
Series/Report:Coordinated Science Laboratory Report no. UILU-ENG-13-2203
Genre:Technical Report
Sponsor:2009-DT-2049 (Princeton/MARCO); 27451040-49741-A (Stanford/DTRA)
Date Available in IDEALS:2016-07-07

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