DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problems
Break (1069); Battery Problem (2885); Material Twisted/Bent (2981)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/05/2019 |
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 upper panel assembly, console cover, and 9v battery then completed pm service.All safety, functionality, and calibration checks were performed 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 console cage for the cardiosave intra-aortic balloon pump (iabp) was observed to be bent, the fiber optic door was missing, and the 9v battery was not functional.It was later clarified that he fiber optic door was broken.There was no patient involved and no adverse event was reported.
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