Model Number 0998-00-0800-52 |
Device Problems
Failure to Charge (1085); Battery Problem (2885)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/20/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that the cardiosave intra-aortic balloon pump (iabp) had a battery issue.
|
|
Manufacturer Narrative
|
A supplemental report will be submitted upon completion of our investigation.
|
|
Event Description
|
It was reported that during a pre use check, the cardiosave intra-aortic balloon pump (iabp) had a battery issue.No patient was involved.
|
|
Manufacturer Narrative
|
Additional information: e1 (event site state: (b)(6)).It was reported that the cardiosave intra aortic balloon pump (iabp) unit not charging batteries.No patient involvement.A getinge field service engineer (fse) says unit tested ok, the unit passed after monitoring,unit returned to customer for clinical use.
|
|
Event Description
|
N/a.
|
|
Event Description
|
It was reported that during a pre use check, the cardiosave intra-aortic balloon pump (iabp) had a battery issue.Batteries didn't charge.No patient was involved.
|
|
Search Alerts/Recalls
|