There was no patient involvement.Livanova (b)(4) manufactures the s5 control panel mrp 85.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.He replaced the processor board and was thus able to remove the reported problem.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The analysis of the serial read-out has been performed and could confirm the reported problem.Multiple error messages were found confirming the failure.The affected board was requested back to the manufacturer site for a detailed investigation.Results revealed that no deviations could be found on the board thus, the exact root cause of the interruption could not be identified.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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