DATASCOPE CORP. - MAHWAH CARDIOSAVE POWER SUPPLY; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Power Problem (3010)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/21/2020 |
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 service territory manager (stm) reported that the portable power supply has a loose power receptacle, one of the long studs/screw that holds on the retaining clip, broke off and fell out.The stm ordered a new portable power supply for replacement and having it shipped directly to customer.No measurement details available, portable power supply is separate from the iabp.The unit was not made available.This was noticed during an inspection of the iabp and accessories.
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Event Description
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It was reported by the customer that during an inspection of the carrdiosave intra-aortic balloon pump (iabp) and accessories, it was discovered that the portable power supply was damaged.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Updated fields: b4, g4, g7, h2, h6 (evaluation method code), h10.
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Event Description
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It was reported by the customer that during an inspection of the carrdiosave intra-aortic balloon pump (iabp) and accessories, it was discovered that the portable power supply was damaged.There was no patient involvement, and no adverse event reported.
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