There was no patient involvement.Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A livanova field service representative investigated the device and could not confirm the reported issue.He tested the unit cooling down and heating water and the set temperatures were reached without showing issues.However, as precaution, he replaced the ac mains board.Functional verification testing was completed without further issues and the unit was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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