There was no patient involvement.Livanova (b)(4) manufactures the s5 double head 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 issue.The device was working within specifications.However, the technician decided to replace the push-button switch.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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