TERUMO CDI 100 MONITOR
Received Jul 3, 2013 · Event occurred Jun 11, 2013
Report 1828100-2013-00689 · MDR key 3214221
Device
Product problems
- Crack
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE REPORTED ISSUE WAS CONFIRMED BY VISUAL INSPECTION. CORROSION WAS EVIDENT ON THE BATTERY WHERE IT WAS EXPOSED. THIS PRODUCT IS BEING PHASED OUT IN THE GLOBAL MARKET. SERVICE AND REPLACEMENT PARTS ARE NO LONGER AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.
Description of Event or Problem
IT WAS REPORTED BY THE CUSTOMER THAT THE BATTERY WAS CRACKED ON THE BLOOD PARAMETER MONITOR (BPM). THIS WAS A BACKUP BATTERY AND WAS FOUND WHILE WALKING BY THE BATTERY SITTING ON A CHARGER. THIS WAS NOT PERTAINING TO ANY CASE OR SETUP, AND THERE WAS NO PATIENT INVOLVEMENT.