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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 2014 2015 2016
2 2 6 4 8 10 6 7 15 11

Device Problems
Device operates differently than expected 43
Failure to power-up 21
Device displays error message 19
Battery issue 19
Inappropriate shock 14
Device inoperable 12
Artifact 7
Inappropriate or unexpected reset 7
Reset issue 6
No display or display failure 6
Detachment of device component 4
Communication or transmission issue 4
Device sensing issue 3
Failure of device to self-test 3
Break 3
Gel leak 3
Failure to charge 2
Loss of power 2
Bent 2
Device alarm system issue 2
Connection issue 2
Use of Device Issue 2
Improper or incorrect procedure or method 2
Defective item 2
No Information 1
No Known Device Problem 1
Seal, defective 1
Cut in material 1
Structural problem 1
Device stops intermittently 1
Material separation 1
Charging issue 1
Patient-device incompatibility 1
False alarm 1
Not audible alarm 1
Burn of device or device component 1
Component falling 1
Fluid leak 1
Leak 1
Mechanical issue 1
Melted 1
Device emits odor 1
Oversensing 1
Total Device Problems 209

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