MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Jul 20, 2012 · Event occurred Jun 27, 2012
Report 1828100-2012-01030 · MDR key 2670255
Device
Product problems
- Break
- Leak/Splash
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
THE SERVICE REPAIR TECHNICIAN REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE BATTERY PACK THAT WAS BROKEN AT BOTTOM SIDE AND LEAKING BATTERY ACID. THERE WAS NO PT INVOLVEMENT OR HARM TO THE USER.
Additional Manufacturer Narrative
EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED. THE REPORTED COMPLAINT WAS CONFIRMED BY THE FIELD SERVICE REP (FSR). THE REPAIR CENTER REPLACED THE BATTERY PACK.