(b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group deutschland received a report that the s5 gas blender was displaying errors during installation.The air, co2 and fio2 flow was set at 2.5 but dropped to 1.1 followed by a modular/sensor defective and set alarm.Sorin group (b)(4) investigation found no failures.All testing performed found no errors.In addition, a test run and a stk check showed no deviations.No nonconformities were noted during manufacturing record review.The issue will be monitored for trends and if identified, corrections will be recommended.
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