Document Detail

Analysis of Automated External Defibrillator Device Failures Reported to the Food and Drug Administration.
MedLine Citation:
PMID:  21872969     Owner:  NLM     Status:  Publisher    
STUDY OBJECTIVE: Automated external defibrillators are essential for treatment of cardiac arrest by lay rescuers and must determine when to shock and if they are functioning correctly. We seek to characterize automated external defibrillator failures reported to the Food and Drug Administration (FDA) and whether battery failures are properly detected by automated external defibrillators. METHODS: FDA adverse event reports are catalogued in the Manufacturer and User Device Experience (MAUDE) database. We developed and internally validated an instrument for analyzing MAUDE data, reviewing all reports in which a fatality occurred. Two trained reviewers independently analyzed each report, and a third resolved discrepancies or passed them to a committee for resolution. RESULTS: One thousand two hundred eighty-four adverse events were reported between June 1993 and October 2008, of which 1,150 were failed defibrillation attempts. Thirty-seven automated external defibrillators never powered on, 252 failed to complete rhythm analysis, and 524 failed to deliver a recommended shock. In 149 cases, the operator disagreed with the device's rhythm analysis. In 54 cases, the defibrillator stated the batteries were low and in 110 other instances powered off unexpectedly. Interrater agreement between reviewers 1 and 2 ranged by question from 69.0% to 98.6% and for most likely cause was 55.9%. Agreement was obtained for 93.7% to 99.6% of questions by the third reviewer. Remaining discrepancies were resolved by the arbitration committee. CONCLUSION: MAUDE information is often incomplete and frequently no corroborating data are available. Some conditions not detected by automated external defibrillators during self-test cause units to power off unexpectedly, causing defibrillation delays. Backup units frequently provide shocks to patients.
Lawrence A Deluca; Allan Simpson; Dan Beskind; Kristi Grall; Lisa Stoneking; Uwe Stolz; Daniel W Spaite; Ashish R Panchal; Kurt R Denninghoff
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-8-26
Journal Detail:
Title:  Annals of emergency medicine     Volume:  -     ISSN:  1097-6760     ISO Abbreviation:  -     Publication Date:  2011 Aug 
Date Detail:
Created Date:  2011-8-29     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8002646     Medline TA:  Ann Emerg Med     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2011 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.
Arizona Emergency Medicine Research Center, University of Arizona Department of Emergency Medicine, Tucson, AZ.
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