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
Overheating of Device (1437)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/19/2023 |
Event Type
malfunction
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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) is overheating.
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Manufacturer Narrative
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Corrected data: b5, b6, b7, d10, h6 (clinical and impact code).Updated data: b4, e1 (initial reporter and email), e2, e3, g3, g6, h2, h10, h11.
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Event Description
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It was reported that prior to use on a patient, the cardiosave intra-aortic balloon pump (iabp) is overheating.There was no patient involved.
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Manufacturer Narrative
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A getinge field service engineer(fse) evaluated unit.Reviewed logs, nothing in logs recent that point to temperature issues, cannot repeat fault.Compressor was replaced in november 2023.Replaced fan and compressor temp probe as a precaution.Completed checkout including all functional and safety tests as per manufacturer specifications.Returned unit to customer.
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