Model Number N/A |
Device Problem
Filling Problem (1233)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 08/16/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge field service engineer (fse) evaluated the iabp and found that k10 would not actuate (no click or action) and k8 would not function when k10 was active in the system.The fse found that there was a burnt component (q7) on the solenoid control board that was associated with k10.He replaced both the solenoid control board and the pneumatics assembly (including k10) and completed preventative maintenance (pm).During the pm, the fse observed that the batteries were expired and as a result, the iabp was not cleared for clinical use.The customer will be ordering new batteries and the iabp will be returned to clinical service upon replacement of the main lithium batteries.All other functional and safety tests were passed to factory specifications.
|
|
Event Description
|
It was reported that during pm service by in-house biomed the cardiosave intra-aortic balloon pump (iabp) was unable to autofill.There was no patient involvement or adverse event was reported.
|
|
Manufacturer Narrative
|
The suspected defective solenoid driver board (the board) was returned to getinge's national repair center for failure analysis.A technician of the nrc inspected the board and observed that component q7 was burnt.The nrc was thus unable to test the board due to the burnt component, and sent the board to the supplier for further testing.Subsequently, the supplier returned the board to the nrc; the supplier's root cause analysis was that the board was not repairable due to the burnt component.The board will be scrapped per procedure.
|
|
Event Description
|
It was reported that during preventative maintenance (pm) service by in-house biomed the cardiosave intra-aortic balloon pump (iabp) was unable to autofill.There was no patient involvement or adverse event was reported.
|
|
Search Alerts/Recalls
|