DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/02/2019 |
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) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.The stm replaced the fiber optic sensor extension cable then completed pm service.In addition, the stm also replaced the ecg trunk cable, cable tie and the batteries then completed pm service.The stm completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.(b)(6).
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Event Description
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It was reported that during preventative maintenance (pm) performed by a getinge service territory manager (stm), the cardiosave intra-aortic balloon pump (iabp) had a broken fiber-optic module.It was later clarified that the fiber-opic sensor extension was broken.Since the event occurred during pm service, there was no patient involvement.In addition, no adverse event was reported.
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