Model Number 0998-00-0800-53 |
Device Problem
Component Incompatible (1108)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: the fse replaced the drive manifold assembly then completed pm service.All safety, functionality, and calibration checks were performed and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.A supplemental report will be submitted upon completion of our investigation.The initial reporter named is a getinge employee who has different contact details from that of the event site.A contact person at the event site is currently unknown.
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Event Description
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It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) had a drive manifold failure.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Additional information: event site telephone: (b)(6).
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Event Description
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N/a.
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Search Alerts/Recalls
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