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 and he could not reproduce the reported failure.However, it could be confirmed through pump serial read-out which revealed multiple occurrences of the reported error.The shaft angle encoder has been replaced and the issue solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A defective shaft angle encoder caused the reported event.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|