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 Problem
Failure to Sense (1559)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: a getinge field service engineer (fse) evaluated the iabp unit for the reported "ap optical sensing module failure" which indicated on screen at startup.The alarm no longer showed up after running the fiber optic test, but the fse replaced the fiber optic module due to the intermittent issue.Did troubleshooting with the customer by turning the unit on and off several times with no errors.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.A supplemental report will be submitted upon completion of our investigation.
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Event Description
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It was reported that before patient use the cs300 intra-aortic balloon pump (iabp) experienced an arterial pressure (ap) optical sensing module failure.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Analysis of production: (3331/213) 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: (4109/213) 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 oct 2019 through sep 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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