There was no patient involvement.Livanova (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).The affected device was returned to the manufacturer site for a detailed investigation.No deviation could be identified.The device was found to be working according to the specifications.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.
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