There was no patient involvement.Livanova deutschland manufactures the heater-cooler system 3t.The incident occurred in (b)(6).The service representative who identified the issue traced the failure to a defective processor board.The technician replaced the board to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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