MalfunctionDTY
TERUMO CDI 101 MONITOR
Received May 9, 2011 · Event occurred Apr 14, 2011
Report 1828100-2011-01243 · MDR key 2094928
Device
Product problems
- Device Displays Incorrect Message
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE QUALITY ENGINEER REPORTED A HEMATOCRIT SATURATION PROBE COLOR CHIP FAILURE AT START-UP. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.