There was no patient involvement.The heater-cooler 16-02-82 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 and confirmed the reported issue.The cause of the problem was a defective cooling compressor.The device will be replaced with another.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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