There was no patient involvement.The s5 control panel sm000015 is not distributed in the usa, but it is similar to the device 28-95-85, which is distributed in the usa (510(k) number: k071318).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 traced the failure to a faulty s5 control panel.The panel was replaced to resolve the issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The replaced device was returned to livanova (b)(4) for further evaluation.The reported issue was confirmed during testing.Visual inspection identified bad soldering joints on an internal circuit bored, which caused the reported issue.The component was re-soldered and no further errors were detected.The board was discarded as a precaution and a new board was installed.Subsequent testing did not identify further issues and the device was returned to the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
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