There was no patient involvement.The event date is unknown.This information will be provided in a supplemental report if made available.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 field service representative was dispatched to the facility to investigate the device and could confirm the issue.He addressed the failure back to a defective compressor.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.Corrective actions are in progress for this issue.
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