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 service representative was able to confirm the reported issue.The root cause was found to be a defective board.The defective part has been replaced.Mechanical test, tubing calibration, test run and tsi were performed; all checks passed with no further issues identified.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Evaluated on site by livanova technician.
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