MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Mar 5, 2015
Report 1828100-2015-00147 · MDR key 4597349
Device
Product problems
- Crack
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE BATTERY WAS CRACKED IN THE BLOOD PARAMETER MONITOR (BPM). THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THE REPORTED COMPLAINT WAS CONFIRMED. THE BATTERY IS DAMAGED AND HAS LEAKED INTERNAL FLUID INTO THE UNIT. THE PRODUCT HAS BEEN MOVED TO THE SERVICE DEPARTMENT FOR DISPOSITION AND WILL BE SCRAPPED. IF ADDITIONAL INFORMATION BECOME AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.