DATASCOPE MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Failure of Device to Self-Test (2937)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/23/2018 |
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.The getinge fse replaced the batteries to fix the issue, and performed full 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.The initial reporter named is a getinge employee who has different contact details from that of the event site, and has the following contact information: (b)(6).
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Event Description
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It was reported that during a preventive maintenance (pm) performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) failed the battery run time test.There was no patient involvement, and there was no adverse event reported.
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