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 06/21/2021 |
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 unit and was able to reproduce the reported issue.The fse verified issue with membrane leak test during all manifold test, was failing, to fix the issue he replaced the pim and re-ran the test and unit passed test.The fse 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.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) was failing the all manifold test.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
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Manufacturer Narrative
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Updated fields: b4,e1(site country),g3,g6,g7,h2,h6(type of investigation, investigation findings, investigation conclusions),h10.
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