Updated fields: a1, a3(to be left blank), b4, b5, d4(version or model #), e1(event site telephone & email), e2, e3, g2, g3, g6, h2, h6, h10.The getinge field service engineer (fse) that had evaluated the iabp and identified the issue with the power supply assembly charger, reported that the reported issue was reproducible, and the power supply assembly charger was replaced to correct the problem.All functional and safety checks to meet factory specifications was performed.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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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 12 month product complaint trend data for the period ( dec 2019 through nov 2020) was reviewed.There were no triggers identified for the review period.
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