There was no patient involvement.Livanova (b)(4) manufactures the s5 control panel mrp.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue and identified a loose speed control knob.The control panel was opened, all circuit boards were disassembled and the speed control knob was tightened to resolve the reported malfunction.Subsequent functional verification testing was completed without further issues and the unit was returned to service a review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Evaluated on site by livanova rep.
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