MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Nov 22, 2011 · Event occurred Oct 26, 2011
Report 1828100-2011-03738 · MDR key 2383959
Device
Product problems
- Break
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE SERVICE TECHNICIAN REPORTED THAT THE BATTERY PACK WAS BROKEN. 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.