There was no patient involvement.Livanova (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was not able to confirm the reported issue.The device worked according the specification.Livanova (b)(4) requested the gas blender back for further investigation.However the gas blender was not made available.Therefore no further investigation could be performed.As the issue could not be reproduced or confirmed, a root cause was not identified.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.Device not returned.
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