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 device but he was not able to reproduce the issue.Functional verification testing was completed without further issues and the unit was returned to service.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.
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