MalfunctionDTY
TERUMO CDI 101 MONITOR
Received May 27, 2011 · Event occurred May 5, 2011
Report 1828100-2011-01523 · MDR key 2118042
Device
Product problems
- Device Displays Incorrect Message
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem
DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE SERVICE TECHNICIAN REPORTED THAT FATAL FAULTS (80, 50, 30) WERE LISTED IN EEPROM. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.