MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Apr 8, 2011 · Event occurred Mar 16, 2011
Report 1828100-2011-00866 · MDR key 2078185
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE MONITOR FAILED TO GO INTO "STAND BY" MODE. THE DEVICE WAS NOT CHANGED OUT. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO A PT DURING THIS EVENT.