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 03/17/2023 |
Event Type
malfunction
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Event Description
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It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) , the cardiosave intra-aortic balloon pump (iabp) unit cannot adjust drive regulator.There was no patient involvement.
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of our investigation.
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Manufacturer Narrative
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The getinge field service engineer (fse) that encountered the reported issue during the preventative maintenance (pm) replaced driver regulator to fix the issue and performed a full functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The pm was completed and the iabp was then released 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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