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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device over-the-counter automated external defibrillator
Regulation Description Automated external defibrillator system.
Definition Automated external defibrillators are devices that use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation. These devices are intended to be used on suspected victims of sudden cardiac arrest. A person in cardiac arrest is unresponsive and is not breathing normally. The device can be sold over-the-counter without a prescription. The device is to be used on adults and children who are either > 8 years old or > 55 lbs.
Product CodeNSA
Regulation Number 870.5310
Device Class 3


Premarket Reviews
ManufacturerDecision
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 16
Failure of device to self-test 8
Noise, Audible 3
Device displays error message 2
Self-activation or keying 1
Material integrity issue 1
No Known Device Problem 1
Total Device Problems 32

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 1 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Philips Medical Systems II Mar-23-2010
2 Philips Medical Systems II Jul-09-2008

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