DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A getinge field service engineer (fse) was dispatched to the customer's site.The fse evaluated the iabp unit and found the fiber optic connector on the iabp to be broken.To fix the issue, the fse replaced the fiber optic connector, 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.
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Event Description
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It was reported that during use on a patient, the fiber-optic sensor of the cardiosave intra-aortic balloon pump (iabp) was not working.The iabp was swapped for another iabp.No patient harm, serious injury or adverse event was reported.
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Search Alerts/Recalls
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