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).Livanova field service representative dispatched to the customer's facility was able to confirm the issue.To solve the issue the stirrer motor and the distribution board were replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.
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