DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Application Program Freezes, Becomes Nonfunctional (4031)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/01/2019 |
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) evaluated the iabp and was unable to reproduce the reported issue.The fse started the iabp numerous times without any issue.The fse performed auto-fill and the iabp pumped.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 when the cardiosave intra-aortic balloon pump (iabp) was turned on, the screen was stuck on with a spinning circle.There was no patient involvement, and there was no adverse event reported.
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Search Alerts/Recalls
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