MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Mar 7, 2011 · Event occurred Feb 10, 2011
Report 1828100-2011-00513 · MDR key 2030304
Device
Product problems
- Device Displays Incorrect Message
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 DISPLAYED A "STAND BY" ERROR CODE AND FAILED TO OPERATE. THE USER REPORTED THREE OCCURRENCES OF THIS SAME EVENT. THE DEVICE WAS NOT CHANGED OUT FOR THE REMAINDER OF THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO A PATIENT DURING THIS EVENT.