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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)
2014 2015 2016 2017 2018 2019
7 15 15 12 8 14

Device Problems
Device Operates Differently Than Expected 34
Monitor 27
Failure to Power Up 19
Inappropriate Shock 14
Device Displays Incorrect Message 9
Device Inoperable 8
Signal Artifact 7
Inappropriate or Unexpected Reset 7
Reset Problem 6
Device Sensing Problem 4
Communication or Transmission Problem 4
Battery Problem 4
Battery 4
Electrode 3
Failure of Device to Self-Test 3
Adverse Event Without Identified Device or Use Problem 2
Use of Device Problem 2
Improper or Incorrect Procedure or Method 2
Loss of Power 2
Seal, defective 1
Cut In Material 1
Structural Problem 1
Defective Device 1
Belt 1
Wire 1
Detachment Of Device Component 1
Component Falling 1
No Display / Image 1
Gel Leak 1
High impedance 1
Over-Sensing 1
Battery Charger 1
Insufficient Information 1
Connection Problem 1
Charging Problem 1
Failure to Fire 1
Patient-Device Incompatibility 1
Failure to Convert Rhythm 1
False Alarm 1
No Audible Alarm 1
Total Device Problems 182

Recalls
Manufacturer Recall Class Date Posted
1 Zoll Manufacturing Corp. II Jan-14-2018

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