A getinge field service technician (fse)reported that cardiosave cannot charge battery sometimes.The fse replaced exch pcb, power management, rohs (0670-00-1162 ) and the unit was working and was able to charged the battery.Performed all functional and safety checks to meet factory specifications.The iabp was return to customer and cleared for clinical use.
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Updated fields: b4, g4, g7, h2, h6 (type of investigation), h10, h11.Corrected field: h4.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 mar 2019 through feb 2021 was reviewed.There were no triggers identified for the review period.
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