MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Mar 18, 2011 · Event occurred Feb 23, 2011
Report 1828100-2011-00649 · MDR key 2040528
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem
DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE MONITOR POWERED UP AND THEN SHUT DOWN. THE DEVICE WAS USED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT A RESULT OF THIS EVENT.