MalfunctionDTY
TERUMO CDI 100 MONITOR
Received Jan 7, 2013 · Event occurred Dec 12, 2012
Report 1828100-2013-00032 · MDR key 2907017
Device
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE QUALITY ENGINEERING REPORTED THAT DURING EVALUATION OF THE DEVICE AT THE LABORATORY, A MOUNTING BRACKET WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THE COMPLAINT WAS CONFIRMED BY LABORATORY ANALYSIS. THE PRODUCT WILL BE SENT TO SERVICE TO BE BROUGHT TO MANUFACTURERS SPECIFICATIONS BEFORE BEING RETURNED TO THE CUSTOMER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.