DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-53 |
Device Problem
Failure to Calibrate (2440)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device (10/213): the getinge field service engineer (fse) attempted to resolve the issue by replacing the video generator board.However, the issue persisted.The fse removed the video generator board replacement and re-installed the original video generator board.The fse resolved the issue by replacing the touch screen assembly, and was then able to calibrate the touch screen.The fse then performed a full pm with calibration, functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.Upon completion of our investigation, a supplemental report will be submitted.The initial reporter named is a getinge employee who has different contact details from that of the event site.A contact person at the event site is (b)(6), biomedical engineer, (b)(6).
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Event Description
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It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the cardiosave intra-aortic balloon pump (iabp) touchscreen would not complete the calibration, despite several attempts.There was no patient involvement, and no adverse event reported.
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Event Description
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N/a.
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Manufacturer Narrative
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Updated fields: b4, g3, g6, g7, h2, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected fields: h4, h6 (component codes).
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