DocumentCode :
1456179
Title :
A shocking truth
Author :
Harris, Mark
Volume :
49
Issue :
3
fYear :
2012
fDate :
3/1/2012 12:00:00 AM
Firstpage :
30
Lastpage :
58
Abstract :
This paper discusses automated external defibrillators design and malfunctions. The paper also discusses how FDA addresses this issues such as reclassification despite claim by manufacturers that reclassification will double or triple the development time for new devices.
Keywords :
defibrillators; pacemakers; FDA; automated external defibrillators; development time; malfunctions; reclassification; Built-in self-test; Cardiac arrest; Cardiology; Defibrillation; Electric shock;
fLanguage :
English
Journal_Title :
Spectrum, IEEE
Publisher :
ieee
ISSN :
0018-9235
Type :
jour
DOI :
10.1109/MSPEC.2012.6156861
Filename :
6156861
Link To Document :
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