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Model Number N/A |
Device Problem
Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A getinge field service engineer (fse) was dispatched to evaluate the iabp and was unable to reproduce the reported issue.To fix the issue, the fse replaced power supply, and the battery indication was displayed on the screen.Unit passed all functional and safety test per 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 a routine check, the cs100 intra-aortic balloon pump (iabp) showed the battery status as empty even thought the unit worked on the battery.There was no patient involvement, and no adverse event reported.
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Manufacturer Narrative
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Analysis of production: ((b)(4)) 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: ((b)(4)) 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: ((b)(4)) the overall 24 month product complaint trend data for the period (mar 2019 through feb 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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