Model Number 0998-00-3023-53 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).Testing of actual/suspected device (10/213): the getinge field service engineer (fse) that encountered the issue replaced the 12v battery and completed the pm with full calibration, functional and safety checks to meet factory specifications.Unit passed all calibration, 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 if this information is provided to us.
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Event Description
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It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse), the cs300 intra-aortic balloon pump (iabp) failed the battery runtime.There was no patient involvement, and no adverse event reported.
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Event Description
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N/a.
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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 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 aug 2019 through jul 2021 was reviewed.There were no triggers identified for the review period.
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Search Alerts/Recalls
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