Model Number 0998-00-0800-53 |
Device Problem
Failure to Read Input Signal (1581)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to investigate.The fse tested the ecg jack with mini simulator which operated to specifications.The fse was unable to reproduce the reported issue.As a precautionary measure, the fse cleaned the ecg jack.Moreover, the end user tested the external ekg jack which functioned to specifications.The fse then performed functional and safety checks to meet 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 during use on a patient, the ekg/ecg port of the cardiosave intra-aortic balloon pump (iabp) was malfunctioning and not detecting from bedside monitors.The end user switched to another unit to continue therapy.No patient harm, serious injury or adverse event was reported.
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Manufacturer Narrative
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Analysis of production: (3331) 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) 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) the overall 24 month product complaint trend data for the period ( jun 2019 through may 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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