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 able to confirm the reported issue.He traced the issue to a pulled mains lead which was unplugged from the first mains connector after the cable enters the housing.The retaining grommet assembly was found to be loose enough to allow moderately easy movement of the main cable through it.No abnormalities were identified in the mains cable retaining grommet, mains plug and mains cable.The field service representative reconnected the cable to its connector and secured the cable in the grommet.Subsequent 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.Evaluated on site by livanova rep.
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