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 10/06/2021 |
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 field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) failed the drive manifold test.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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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).The getinge field service engineer (fse) that encountered the issue replaced the drive manifold assembly and completed the pm with full calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, 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 when this information is provided to us.
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Event Description
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N/a.
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Manufacturer Narrative
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Updated fields: b4, g3, g6, g7, h2, h4, h6, h10.
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