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
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2021 |
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) failed the all manifold test.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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During a preventative maintenance (pm) service, the getinge field service engineer (fse) discovered that the unit failed the all manifold, drive manifold portion, vacuum test.The fse narrowed down the issue to the drive manifold, since nothing unusual was found in the logs.To fix the issue he replaced the drive manifold and successfully completed an all manifold test.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 full name of the initial reporter that is abbreviated is (b)(6).The initial reporter named in 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), biomed.
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