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
Component Incompatible (1108)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: (10/213) a getinge field service engineer (fse) evaluated the iabp for the reported "during pm, fails drive manifold tests", to fix the issue the fse replaced the drive manifold which the corrected the issue.He then 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.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 (b)(6).
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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) failed the drive manifold tests.There was no patient involvement, and no adverse event reported.
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Event Description
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N/a.
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Search Alerts/Recalls
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