Device product
Cardiosave Hybrid and rescue IABP
Z-1248-2016
Product summary
- Event
- Event 72890
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1243 units US; 1107 units OUS
- Official record key
device-enforcement:Z-1248-2016
Official wording
Reason: Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.
Code information: Cardiosave Hybrid IABP 0998-00-0800-53,0998-UC-0800-53, Cardiosave Rescue IABP 0998-00-0800-83 & 0998-UC-0800-83
Distribution pattern: Worldwide Distribution- Nationwide Distribution including Puerto Rico.
Derived failure modes
-
Unknown
Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.