MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Jan 31, 2011 · Event occurred Jan 6, 2011
Report 1828100-2011-00082 · MDR key 1981611
Device
Product problems
- Device Displays Incorrect Message
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
DURING FIELD SERVICE INSTALLATION OF THE DEVICE, THE USER REPORTED TWO FLASH CARDS FAILED AND DISPLAYED A "FAULT 5" ERROR MESSAGE. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THIS EVENT OCCURRED DURING FIELD SERVICE INSTALLATION, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.