DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-53 |
Device Problem
Circuit Failure (1089)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/23/2021 |
Event Type
malfunction
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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) unit needed a replacement chassis bracket because it was stripped.There was no patient involvement.
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Manufacturer Narrative
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It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), had to replace a stripped chassis bracket on the cardiosave intra-aortic balloon pump (iabp).The getinge field service engineer (fse) that discovered a stripped chassis bracket.The fse replaced the stripped bracket (0406-00-0948) during pm and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.This report is being submitted as the result of a retrospective review conducted in capa (b)(4).
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Event Description
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N/a.
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Search Alerts/Recalls
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