Device product
Cardiosave Rescue. Model Number: 0998-00-0800-83.
Z-1232-2023
Product summary
- Firm
- Datascope Corp.
- Event
- Event 91642
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 47 units (44 US, 3 OUS)
- Official record key
device-enforcement:Z-1232-2023
Official wording
Reason: Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.
Code information: Model Number: 0998-00-0800-83. UDI-DI: 10607567108407. All serial numbers.
Distribution pattern: Nationwide US distribution. Worldwide international distribution.
Derived failure modes
-
Unknown
Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.