DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE G PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-52 |
Device Problem
Failure to Power Up (1476)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate the iabp and was unable to reproduce the reported issue.The fse calibrated the touch screen to resolve the issue.All 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 start up, the cardiosave intra-aortic balloon pump (iabp) failed power-up test #6.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Historical data analysis: (4109/114) the review of the historical data indicates that no other similar complaint was reported for the same serial number and reported failure mode.Analysis of production: (3331/114) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Trend analysis: (4110/114) the overall 24 month product complaint trend data for the period mar-2019 through feb-2021 was reviewed.There were no triggers identified for the review period.
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Search Alerts/Recalls
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