MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Mar 25, 2011 · Event occurred Feb 4, 2011
Report 1828100-2011-00736 · MDR key 2064640
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 FIELD SERVICE INSTALLATION OF THE DEVICE, THE USER REPORTED THAT THE FLASH CARD FAILED AND DISPLAYED A "FAULT 5" ERROR MESSAGE. SINCE THIS EVENT OCCURRED DURING FIELD SERVICE INSTALLATION, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.