MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Aug 19, 2011 · Event occurred Jul 27, 2011
Report 1828100-2011-02513 · MDR key 2246243
Device
Product problems
- Image Orientation Incorrect
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DURING USE OF THE DEVICE FOR CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THE SCREEN WOULD INTERMITTENTLY TURN BLUE. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.