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.The service representative confirmed the reported issue and was unable to correct the problem by rebooting the device.The service representative re-seated all connections on the back plane, cpu and interface boards, but the issue persisted.The cpu board was replaced and the issue was resolved.Subsequent testing found the device to be functioning according to specifications.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.Device not returned.
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