MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Feb 24, 2011 · Event occurred Feb 2, 2011
Report 1828100-2011-00416 · MDR key 2022962
Device
Product problems
- Fracture
- Leak/Splash
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 SVC CTR, THE SVC TECHNICIAN REPORTED THAT THE BOTTOM OF THE BATTERY WAS CRACKED AND WAS LEAKING. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING OF THE DEVICE, THERE WAS NOT PT INVOLVEMENT DURING THIS EVENT.