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 Problem
Device Displays Incorrect Message (2591)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) evaluated the iabp, but was unable to reproduce the reported "internal fault" issue.The fse did find electrical test failures code 115, and a communication error.To fix the issue, he replaced the executive processor pcb and reloaded the b17 software.He also, recalibrated the 30 psi transducer and the helium transducer.Completed full calibration, unit passed all functional and safety tests per factory specifications and was returned to the customer and cleared for clinical use.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 during use on a patient the cardiosave intra-aortic balloon pump (iabp) had an internal fault.No patient harm, serious injury or adverse event was 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 sep 2019 through aug 2021 was reviewed.There were no triggers identified for the review period.
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Event Description
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It was reported that during use on a patient the cardiosave intra-aortic balloon pump (iabp) stopped pumping, the ekg went flat line and an internal fault was displayed.No patient harm, serious injury or adverse event was reported.
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Search Alerts/Recalls
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