Device product
Cardiac Workstation 5000; Model Number: 860439;
Z-0165-2026
Product summary
- Event
- Event 97612
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 28 units
- Official record key
device-enforcement:Z-0165-2026
Official wording
Reason: Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
Code information: Model Number: 860439; UDI-DI: 00884838094826; Serial Numbers:
Distribution pattern: US Nationwide distribution in the states of CA, IA, TN, TX, VA.
Derived failure modes
-
Unknown
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.