DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE I PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-0800-31 |
Device Problem
Failure to Charge (1085)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/16/2021 |
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 able to reproduce the reported issue.The fse determined that the power management pcb was not charging the batteries.To fix the issue, the fse replaced the power management board, and performed all functional and safety checks to meet factory specifications.Unit passed all 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 prior to use, the cardiosave intra-aortic balloon pump (iabp) batteries were not charging due to the charge level indication not changing.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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Analysis of production: (3331/213) the device history record 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: (4109/213) 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: (4110/213) 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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