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.There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.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 and traced the failure to a on-/off switch.The technician replaced the switch to resolve the reported issue.Subsequent functional verification testing was completed without further issues and the unit was returned to service.As the switch was not made available no further investigation could be performed and no specific root cause could be determined.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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