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
Failure to Calibrate (2440); Output below Specifications (3004)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The getinge field service engineer (fse) identified a compressor related issue in the logs with respected to the reported issue.The fse resolved the issue by replacing the scroll compressor, muffler <100 micron and muffler,1/8 npt, and successfully completed pressure and vacuum regulator calibrations without any further issues.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.(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) pressure regulator failed calibration.Specifically, the pressure failed to rise to 390 mmhg +-10, as part of calibration.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Analysis of production: (3331/102) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/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.Historical data analysis: (4109/102) the review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.Trend analysis: (4110/102) the overall 24 month product complaint trend data for the period may 2019 through apr 2021 was reviewed.There were no triggers identified for the review period.
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Search Alerts/Recalls
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