Catalog Number 0998-00-0800-53 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse was able to confirm the issue in the logs.The fse found the connector from the monitor to the base had been disconnected.After reconnecting, the fse tested the iabp and it functioned properly.The iabp was not returned to service due to a missing ecg lead and missing battery which the customer biomed will take care of.
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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) shutdown while on a patient.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 (may 2019 through apr 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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