MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Aug 23, 2011 · Event occurred Aug 1, 2011
Report 1828100-2011-02539 · MDR key 2256409
Device
Product problems
- Device Displays Incorrect Message
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 CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED AN ERROR MESSAGE OF PROBE ERROR. AS A RESULT, AN ALTERNATIVE DEVICE WAS DEPLOYED. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.