Updated fields: b4, g4, g7, h2, h4, h6 (type of investigation, findings and conclusion codes), h10, h11.Corrected fields: e1 (event site name), g1.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 & 67) the overall 24 month product complaint trend data for the period oct 2019 through sep 2021 was reviewed.There were no triggers identified for the review period.A cr/capa/scar/ncmr review was conducted for the two year period oct 2019 through sep 2021.A capa was identified for the reported failure mode ¿battery short run time¿ and product ¿cs300¿.The capa was addressed under a capa request and no escalation to capa is required.The initial reporter named in block e1 is a getinge employee whose contact details differ from that of the event site.Poc at event site: (b)(6).
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