Patient information was not provided.This event was initially considered to be non-reportable.However, after additional evaluation, livanova deutschland has decided to reclassify this event as reportable.This report is being filed as part of a retrospective review conducted in response to this new decision.Livanova (b)(4) manufactures the electrical venous occluder (evo).The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The reported issue was confirmed.The malfunction was resolved by clearing the nvmem from the display and performing a four pinpoint test.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Corrective actions are in progress for this type of issue.Evaluated on site by livanova technician.
|