Device product
LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is indicated for patients 18 years of age and older who are at risk for sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator.
Z-0353-2018
Product summary
- Event
- Event 78926
- Status
- Terminated
- Classification
- Class II
- Quantity
- 33,670 units
- Official record key
device-enforcement:Z-0353-2018
Official wording
Reason: Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure
Code information: All Serial Numbers
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure