There was no patient involvement.Livanova (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The affected device was returned to the manufacturer site for a detailed investigation.Results revealed that the reported issue could be reproduced only once and the exact root cause could not be identified.However, the components potentially involved in this type of issue (o2 valve and o2 flow controller) will be replaced as precaution.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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