MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Apr 1, 2011 · Event occurred Mar 9, 2011
Report 1828100-2011-00822 · MDR key 2077863
Device
Product problems
- Fracture
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 BOTTOM OF THE BATTERY WAS CRACKED. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING OF THE DEVICE, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.