The heater-cooler 16-02-95 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).This event was initially considered to be non-reportable.However, after additional evaluation, livanova (b)(4) has decided to reclassify this event as reportable.This report is being filed as part of a retrospective review conducted in response to this new decision.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 could confirm the reported issue and traced it back to a defective compressor.The unit was returned to livanova (b)(4) for further investigation and repair.During investigation, a hole inside the evaporator was identified as root cause of the reported failure.Corrective actions are in progress for this issue.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
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