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)(4).Livanova requested the device for detailed investigation and repair.During the investigation it was possible to reproduce the reported failure.The device was leaking and deviations in the values were detected.The root cause could be traced back to several defective components.Therefore the measure bridge, a front panel and an eprom were 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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