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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)
2015 2016 2017 2018 2019 2020
15 15 12 8 22 8

Device Problems
Device Operates Differently Than Expected 32
Monitor 24
Failure to Power Up 18
Inappropriate/Inadequate Shock/Stimulation 15
Device Displays Incorrect Message 8
Device Inoperable 7
Inappropriate or Unexpected Reset 7
Signal Artifact/Noise 6
Device Sensing Problem 4
Battery 4
Reset Problem 4
Battery Problem 4
Failure of Device to Self-Test 3
Electrode 3
Communication or Transmission Problem 3
Use of Device Problem 2
Improper or Incorrect Procedure or Method 2
Adverse Event Without Identified Device or Use Problem 2
Patient-Device Incompatibility 1
Battery Charger 1
Belt 1
Failure to Fire 1
High impedance 1
Connection Problem 1
Charging Problem 1
No Display/Image 1
Seal, defective 1
False Alarm 1
Loss of Power 1
Wire 1
Component Falling 1
Failure to Convert Rhythm 1
Cut In Material 1
Insufficient Information 1
Over-Sensing 1
Detachment Of Device Component 1
Total Device Problems 166

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

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