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
Detachment of Device or Device Component (2907)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/11/2022 |
Event Type
malfunction
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Event Description
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It was reported that, the cardiosave intra-aortic balloon pump (iabp) units plastic covers at the hinges of folding display/control unit are missing, exposing electronics and wires.
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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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Event Description
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It was reported that, the cardiosave intra-aortic balloon pump (iabp) units plastic covers at the hinges of folding display/control unit are missing, exposing electronics and wires.There was no patient harm reported.
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Manufacturer Narrative
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Updated data: b4,g3,g6,h2,h10.H11
corrected data: b5,h6(clinical & impact ).
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Event Description
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N/a.
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.To fix the issue, the fse replaced the hinge covers 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 for cleared for clinical service.
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Search Alerts/Recalls
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