There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was not able to confirm the reported issue.However, during visual inspection it was discovered that the mains plug showed signs of heat damage, which may have lead to a loss of power.The mains plug was replaced as a precaution and subsequent functional verification testing was completed without further issues.The unit was returned to service.A specific root cause could not be determined.However, the damaged mains plug is indicative of poor contact between the socket and plug, which is the most likely cause of the issue.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Device evaluated by livanova rep.
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