|
Model Number N/A |
Device Problem
Filling Problem (1233)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 03/06/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A getinge field service engineer (fse) evaluated the iabp unit and determined the malfunction to be a result of the pump not producing sufficient vacuum pressure.To fix the issue, the fse replaced the 5000h pm kit, and performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.
|
|
Event Description
|
It was reported that during use on a patient, the cs100 intra-aortic balloon pump (iabp) an autofill error was displayed.The physician swapped the unit out and continued therapy.No patient harm, serious injury or adverse event was reported.
|
|
Search Alerts/Recalls
|
|
|