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
Device Displays Incorrect Message (2591)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/15/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp, but was unable to reproduce the reported issue.However, the fse was able to verify the alarms in the iabp¿s diagnostic error log.The iabp was able to pass all the leak tests, and the fse performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer for return to 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 by the customer that the cardiosave intra-aortic balloon pump (iabp) unit, before placed in use had "iab catheter restriction" alarm.The unit was swapped out.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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