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 12/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).The getinge field service engineer (fse) that encountered the issue replaced the pneumatic module assembly and performed 30 psi calibration procedure.The fse found the fiber optic connector was damaged and replaced the front end assembly.Pm was completed during the same service visit.Full calibration, functional, and safety checks were performed which passed to meet 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 during preventive maintenance (pm) performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) had a damaged fiber optic connector.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: d1.
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Event Description
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It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) had a damaged fiber optic connector.There was no patient involvement, and no adverse event reported.
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