There was no 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) a livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The failure was traced back to a defective cooling compressor.The unit was removed from service and will be scrapped.
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