Device product
CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion Battery affected part number is 0146-00-0097 Product Usage: The CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons
Z-1386-2017
Product summary
- Event
- Event 76052
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8000
- Official record key
device-enforcement:Z-1386-2017
Official wording
Reason: Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped.
Code information: part number 0146-00-0097
Distribution pattern: Worldwide Distribution - US Nationwide
Derived failure modes
-
Unknown
Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP of the battery venting after being accidentally dropped.