There was no patient involvement.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 service representative was able to confirm the reported issue.It was found that the compressor is causing a short circuit which led to the reported issue.Therefore the device was requested for further investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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The involved device was returned to livanova (b)(4) for further investigation.During the evaluation, the reported failure was reproduced.Inspection identified a leakage inside the evaporator, which was determined to be the root cause of the reported issue.This is a known issue for which corrective action has been initiated.
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