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 09/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device : a getinge field service engineer (fse) evaluated the iabp, but was unable to reproduce the reported issue.The fse turned the iabp unit on to make sure it auto filled and pumped, checked logs and was not able to find any errors.He 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.The full name of the initial reporter that is abbreviated is (b)(6).The full event site name in is (b)(6).
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Event Description
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It was reported that during patient transport the cardiosave intra-aortic balloon pump (iabp) failed.It was later clarified that the iabp unit had shut off.No patient harm, serious injury or adverse event was reported.
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Search Alerts/Recalls
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