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
Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate the iabp and was able to reproduce the reported issue.Upon initially running unit with trainer and catheter, the fse manipulated coiled cord, and display went out, but pump kept running.To fix the issue, the fse replaced the coiled cord and a coiled cord to back plane board, 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 to the customer and cleared for clinical service.A supplemental report will be submitted if this information is provided to us.
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Event Description
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It was reported that during use on a patient, the cardiosave intra- aortic balloon pump (iabp) shut down upon use.The unit was swapped out with another to continue therapy.No patient harm, serious injury or adverse event was reported.
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Manufacturer Narrative
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Updated fields: b4, g4, g7, g8, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: g1(contact person), h6(component codes).
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Event Description
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N/a.
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Search Alerts/Recalls
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