|
Model Number N/A |
Device Problem
Failure to Pump (1502)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 07/15/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse was able to reproduce the issue.After inspection, it is found that the motor drive board (mdb) of the pump head was faulty.The mdb was replaced and the issue was resolved.The iabp unit was cleared for clinical use and released to the customer.
|
|
Event Description
|
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) was turned on, it entered the working mode and a long beeping alarm sounded and it would not work.The customer shut the iabp off and restarted it but the issue remained.No patient harm, serious injury or adverse event was reported.
|
|
Event Description
|
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) was turned on, it entered the working mode and a long beeping alarm sounded and it would not work.The customer shut the iabp off and restarted it but the issue remained.No patient harm, serious injury or adverse event was reported.
|
|
Search Alerts/Recalls
|
|
|