Model Number 0998-00-0800-53 |
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 06/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device (10/213) a getinge field service engineer (fse) evaluated the iabp, but was unable to reproduce the reported "breaks in the bp transducer waver form" issue.The fse could not verify the break, he tried cycling the unit for over an hour and also checked the customers bp cables but was unable to reproduce the issue.The fse then 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 during use on a patient the cardiosave intra-aortic balloon pump (iabp) had ¿breaks¿ in the ap waveform.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 record 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 there was one similar complaint reported for the reported failure mode and serial number.The historical data was analyzed and escalation was not required for the reported failure mode and serial number.Trend analysis: (4110/213) 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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