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).This event was initially considered to be non-reportable.However, after additional evaluation, livanova (b)(4) has decided to reclassify this event as reportable.This report is being filed as part of a retrospective review conducted in response to this new decision.Livanova (b)(4) manufactures the s3 gas blender system.The incident occurred in (b)(6).The defective gas blender system was returned to livanova (b)(4) for further investigation.During the investigation a livanova service engineer was able to confirm the reported issue und could be traced to a defective dc-supply board.Therefore the defective board was replaced to resolve the reported issue.Subsequent 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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