Patient information was not provided.Livanova (b)(4) manufactures the s5 system.The event occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative confirmed the reported issue and returned the dc/dc module to livanova (b)(4) for further investigation.Evaluation of the returned dc/dc module confirmed the reported issue.After several minutes of testing, the output voltage of the module was no longer present.A new dc/dc module was installed on the hdc board and subsequent testing did not identify further issues.The replaced module was dispositioned as scrap.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.
|