There was no patient involvement.The gas blender system 25-40-00 is not distributed in the usa, but it is similar to gas blender system 25-40-45, which is distributed in the usa (510(k) number: k052601).Livanova (b)(4) manufactures the s3 gas blender system.The incident occurred in (b)(6).Livanova (b)(4) requested the device back for further investigation.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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