(b)(4) manufactures the s3 gas blender.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the s3 gas blender alarmed and lost function during a procedure.It alarms and all digital displays flash.When tested on another machine, an error message displayed.The issue was confirmed.The cause was a defective front panel.The panel was replaced and the unit was tested without any problems.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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