There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump console.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate and could confirm the reported failure since the system would not respond to any touchscreen input.He replaced the touchscreen and was thus able to remove the issue.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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