There was no known patient involvement.The heater-cooler 16-02-80 is not distributed in the usa and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Through follow-up communication livanova learned that after performing routine disinfection the lab results were negative and that the device was cleaned regularly as per the instruction for use.The device is placed inside the operating theatre during use with the fan opposite to the operating field at an estimated distance of 2-3 meters.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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