There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.He replaced the shaft angle encoder and the issue was solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A defective shaft encoder led to the reported event.
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