DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
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Model Number 0998-00-3023-53 |
Device Problems
Component Incompatible (1108); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: (10/213) during a preventative maintenance (pm) service, the getinge field service engineer (fse) the iabp failed the drive manifold leak test, to fix the issue the fse replaced the drive assembly.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.A supplemental report will be submitted upon completion of our investigation.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).
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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 cs300 intra-aortic balloon pump (iabp), failed the drive assembly leak test.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 jul 2019 through jun 2021 was reviewed.There were no triggers identified for the review period.
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Event Description
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N/a.
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Search Alerts/Recalls
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