A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 roller pump.The incident occurred in the woodlands, texas.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.In order to fix the issue, motor control board (hms) and motor power amplifier board (hmf) were replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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