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.Patient information was not provided.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).A livanova field service representative was dispatched onsite to investigate.The reported issue could be confirmed and to cure the fault the on-/off-switch was replaced.Subsequent functional verification testing found no further issues and the device was returned to service.A root cause why the switch has failed, could not be determined.A review of the dhr did not identify any deviations or nonconformities relevant to the issue.
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