Testing of actual/suspected device : a getinge service territory manager (stm) was dispatched to evaluate the iabp and was able to reproduce the reported issue.The fse confirmed unit alarmed and displayed "electrical test fails code # 51" upon power up.To fix the issue, per the manual, the stm replaced the motor control pcb using screw labels.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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Updated fields: b4, g4, g7, h2, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10 analysis of production: (3331) 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) 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) the overall 24 month product complaint trend data for the period nov 2019 through oct 2021was reviewed.There were no triggers identified for the review period.
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