DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID DOMESTIC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number N/A |
Device Problem
Battery Problem (2885)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The full name of the event site was shortened due to field character limit; the full name is (b)(6).The initial reporter named in block e1 is a getinge employee who has different contact details from that of the event site.Please refer to the following email and phone number: (b)(6).A getinge field service engineer (fse) evaluated the iabp and found the batteries were expired and replaced them.Unrelated to the reported issue, the executive processor pcb was replaced was removed and replaced.It was also discovered that the fiber optic connector was damaged and replaced.The fse found the p-clip that secures the coiled cable was broken and replaced it.Full calibration was performed and the unit passed all functional and safety tests per factory specifications.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 the cardiosave intra-aortic balloon pump (iabp) had expired batteries.This was discovered during a previously scheduled repair.There was no patient involvement, and no adverse event reported.
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Event Description
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It was reported that the cardiosave intra-aortic balloon pump (iabp) had expired batteries.This was discovered during a previously scheduled repair.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 codes), h10, h11.Corrected fields: b3, d5.
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