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 reproduce and confirm the reported issue.The issue could be traced to a faulty main switch, which showed incomplete contact.The main switch was replaced and a test-run was successfully performed.The device was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.A supplier quality notification has been opened for a this type of issue.Evaluated on site by livanova rep.
|