Patient information: there was no patient involvement.Pma/510k: the heater-cooler 16-02-80 is not distributed in the usa, but it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k052601).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).A livanova service representative was dispatched to the facility to investigate and could confirm the reported issue.He performed the calibration of the temperature sensor and was thus able to remove the failure.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
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