Device product
Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.
Z-1523-2014
Product summary
- Event
- Event 67815
- Status
- Terminated
- Classification
- Class I
- Quantity
- 11,881 units (US 5183 and OUS 6698)
- Official record key
device-enforcement:Z-1523-2014
Official wording
Reason: Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.
Code information: IABP Model Numbers System 98 0998-00-0446-xx 0998-UC-0446-xx System 98XT 0998-00-0479-xx 0998-UC-0479-xx CS100i 0998-UC-0446Hxx 0998-UC-0479Hxx CS100 0998-00-3013-xx 0998-UC-3013-xx CS300 0998-00-3023-xx 0998-UC-3023-xx
Distribution pattern: Worldwide Distribution - USA (nationwide) and approximately 104 countries.
Derived failure modes
-
Manufacturing or process control
assembly failure