Analysis of Automated External Defibrillator Device Failures Reported to the Food and Drug Administration - 17/01/12

Doi : 10.1016/j.annemergmed.2011.07.022

Lawrence A. DeLuca, MD, EdD ^a,^⁎ , Allan Simpson, MD ^b, Dan Beskind, MD ^a, Kristi Grall, MD, MSPE ^a, Lisa Stoneking, MD ^a, Uwe Stolz, PhD, MPH ^a, Daniel W. Spaite, MD ^a, Ashish R. Panchal, MD ^a, Kurt R. Denninghoff, MD ^a
^a Arizona Emergency Medicine Research Center, University of Arizona Department of Emergency Medicine, Tucson, AZ
^b Christus Spohn–Texas A&M, Emergency Medicine Residency, Corpus Christi, TX

Address for correspondence: Lawrence A. DeLuca, Jr, MD, EdD

Résumé

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.

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Plan

Introduction

Background

Importance

Goals of This Investigation

Materials and Methods

Study Design and Setting

Selection of Participants

Methods of Measurement

Data Collection and Processing

Outcome Measures

Primary Data Analysis

Results

Limitations

Discussion

	Publication date: Available online August 27, 2011.
	Provide process.asp?qs_id=7369 on this article at the journal’s Web site, www.annemergmed.com.
	Supervising editor: Judd E. Hollander, MD
	Author contributions: LAD and KRD were responsible for the development of the study as a whole. LAD, AS, LS, US, DS, and AP participated in successive phases of the development and refinement of the data abstraction instrument. LAD drafted the original article and all authors contributed substantially to its revision. LAD and US performed statistical analysis. LAD had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. LAD takes responsibility for the paper as a whole.
	Funding and support: By Annals policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org). The authors have stated that no such relationships exist.
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