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).The technician in charge replaced the distribution board and the patient pump 2 to solve the problem.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A mechanical/electronic failure of the motors circuit boards caused the reported issue.
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