MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Mar 18, 2011 · Event occurred Feb 23, 2011
Report 1828100-2011-00668 · MDR key 2040555
Device
Product problems
- Device Displays Incorrect Message
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
EVAL IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem
DURING PREPARATION OF THE DEVICE FOR CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED A COLOR CHIP FAILURE. AS A RESULT, AN ALTERNATE DEVICE WAS USED FOR THE PROCEDURE. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.