MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Aug 21, 2012 · Event occurred Jul 26, 2012
Report 1828100-2012-01100 · MDR key 2711116
Device
Product problems
- Display or Visual Feedback Problem
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE NUMBERS DISPLAYED ON THE MONITOR ARE NO LONGER ACCURATE. NO OTHER DETAILS REGARDING THE NATURE OF THIS EVENT WERE PROVIDED.
Additional Manufacturer Narrative
LAB ANALYSIS FOUND THE UNIT FAILED THE COLOR CHIP TEST AND HAS A DEFECTIVE OPTO PROBE RELATED TO THE AGE OF THE DEVICE. NO PARTS ARE AVAILABLE FOR REPAIR. IF ADDITIONAL INFO BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.