MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Sep 8, 2011 · Event occurred Aug 15, 2011
Report 1828100-2011-02692 · MDR key 2266104
Device
Product problems
- No Display/Image
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE USER REPORTED THAT WHEN THE MONITOR WAS UNPACKED AND TURNED ON, A BLUE SCREEN APPEARED. SINCE THE EVENT OCCURRED DURING A NON-CLINICAL ACTIVITY, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.
Additional Manufacturer Narrative
EVAL IN PROGRESS, BUT NOT YET CONCLUDED.