Model Number 0998-00-0800-53 |
Device Problems
Failure to Charge (1085); Failure to Run on Battery (1466)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/11/2022 |
Event Type
malfunction
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) detected an unusable battery in bay 1 and bay 2 and the batteries were not charging.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
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Manufacturer Narrative
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Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate the iabp and was unable to reproduce the reported issue.The fse unplugged then plugged the batteries back in and restarted the iabp unit, but the reported issue would not come up.The fse checked the iabp log files and did not observe any error codes.Preventative maintenance (pm) was performed during the same service visit.Full calibration, functional, and safety checks were performed which passed to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate the iabp and was unable to reproduce the reported issue.The fse unplugged then plugged the batteries back in and restarted the iabp unit, but the reported issue would not come up.The fse checked the iabp log files and did not observe any error codes.Preventative maintenance (pm) was performed during the same service visit.Full calibration, functional, and safety checks were performed which passed to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.
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Event Description
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N/a.
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Search Alerts/Recalls
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