Catalog Number 0998-00-3023-53 |
Device Problem
Failure of Device to Self-Test (2937)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 06/27/2018 |
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 the company standard operating procedure since the device manufacture date is greater than one year from the event date.Battery replacement and preventive maintenance (pm) will be performed by the customer.If additional information is provided by the customer, we will submit a supplemental report.The initial reporter is a getinge designee whose contact details are different from that of the event site.Please refer to the following email and phone number as contact information for the initial reporter (b)(6).
|
|
Event Description
|
It was reported that while a getinge designee was performing field action update on the cs300 intra-aortic balloon pump (iabp), the batteries failed the fun time test.There was no patient involvement, and no adverse event was reported.
|
|
Manufacturer Narrative
|
The customer has advised that the batteries were replaced on (b)(6)2018, and the iabp was cleared for clinical service.
|
|
Event Description
|
It was reported that while a getinge designee was performing field action update on the cs300 intra-aortic balloon pump (iabp), the batteries failed the fun time test.There was no patient involvement, and no adverse event was reported.
|
|
Search Alerts/Recalls
|