There was no patient involvement.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).After coordination with technical support from livanova, the customer determined the fault coming from a defective heating element.In order to fix the issue, the customer decided to replace the heating element himself.The device was then put back in service a review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Device not returned.
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