There was no patient involvement.
Livanova (b)(4) manufactures the s5 gas blender system.
The incident occurred in (b)(6).
During the functional test a deviation has been detected between the value of the monitoring sensor from the value of the controlling sensor for the co2.
As cause of the issue a defective co2 monitoring sensor has been identified.
In order to solve the issue, the co2 sensor has been replaced.
Subsequent functional verification testing was completed without further issues and the unit was returned to service.
If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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