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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wearable automated external defibrillator
Definition The device is an automatic external defibrillator which monitors and treats a patient for ventricular defibrillation. Device is intended to be worn in home or in hospital settings as prescribed and overseen by a physician.
Product CodeMVK
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013
2 2 6 4 8 10 1

Device Problems
Battery issue 15
Device displays error message 9
No display or display failure 5
Device inoperable 4
Detachment of device component 3
Device operates differently than expected 3
Break 3
Failure to charge 2
Gel leak 2
Bent 2
Device alarm system issue 2
Mechanical issue 1
Melted 1
Device emits odor 1
Fluid leak 1
Material separation 1
Connection issue 1
Defective item 1
Leak 1
Burn of device or device component 1
Total Device Problems 59

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 1 0 1 1 0 0 0
Class III 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Zoll Lifecor Corporation II Dec-16-2010
2 Zoll Lifecor Corporation II Jan-28-2009
3 Zoll Lifecor Corporation III Oct-18-2007
4 Zoll Lifecor Corporation II Jun-15-2007

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