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 unable to reproduce the reported issue.No error codes were displayed when the heater-cooler system 3t was turned on.The unit was tested for four hours without issue.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Evaluated on site by livanova technician.
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