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 Problems
Component Incompatible (1108); Erratic or Intermittent Display (1182)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.The fse found that the video generator pcb was the cause of the lower touch panel display distortion.To fix the issue, the fse replaced the video generator pcb kit, and calibrated it.The 9 volt battery was due to expire so it was replaced.The fse then performed all calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, functional and safety test 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 during a preventive maintenance (pm) performed by the customer, the generator board needed to be replaced on the cardiosave intra-aortic balloon pump (iabp), due to the lower touch panel display being distorted.There was no patient involvement, and no adverse event reported.
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Search Alerts/Recalls
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