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Model Number 0998-00-3023-53 |
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 06/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Testing of actual/suspected device: (10/213) during a preventative maintenance (pm) service, the getinge field service engineer (fse) discovered that the unit was not producing an alarm tone, he tried fixing the issue by replacing the system speaker, but the issue persisted.The fse then replaced the main board which corrected the issue.The fse then performed a full pm with calibration, functional and safety checks to meet 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.The initial reporter named is (b)(6).
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Event Description
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It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the cs300 intra-aortic balloon pump (iabp) had a no system alarm sound.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Analysis of production: (3331/102) the device history record review concluded that there were no ncmrs, rework, or deviations documented for the reported 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: (4109/102) the review of the historical data indicates that no other similar complaint was reported for the same serial number and reported failure mode.Trend analysis: (4110/102) 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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