MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Aug 15, 2011 · Event occurred Jul 21, 2011
Report 1828100-2011-02445 · MDR key 2229473
Device
Product problems
- Display or Visual Feedback Problem
- Ambient Noise Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE USER REPORTED THAT THE MONITOR BEEPED CONTINUOUSLY WITH A BLUE SCREEN. THE DEVICE WAS POWERED ON AND OFF TWICE WITH THE SAME RESULT. 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.