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 suspected that pump motor is defective.Investigation is ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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H10: a livanova service technician was dispatched to the customer's facility, found the unit drained and was told by hospital biomed that the stirrer motor was hard to turn and it was smoking during the last disinfection cycle.To resolve the problem, service technician changed the stirrer motor out to a new one.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The most likely root cause of the reported event is corrosion/degradation of the motor bearing, probably due to environmental conditions, which caused the stirrer motor to get stuck and the machine to use more power to work, which could have led to an over-current that ultimately caused the device to emit smoke and smell like a burning smell.
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