MalfunctionEHD
CARESTREAM 2400P
Received Jun 20, 2024 · Event occurred Jun 7, 2024
Report MW5156405 · MDR key 19582875
Device
Product problems
- Product Quality Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ADDITIONAL INFORMATION RECEIVED ON 8/7/2024 FOR REPORT MW5156404 TO UPDATE THE MANUFACTURER TO NANORAY CO., LTD.
Description of Event or Problem
WE PURCHASED 3 HANDHELD X-RAY DEVICES (2400P) FROM CARESTREAM. ALL 3 DIED AT AROUND THE SAME TIME. WE PAID APPROXIMATELY (B)(6) FOR EACH OF THEM IN THE SPRING/SUMMER OF 2022. THE COMPANY IS ASKING US TO PAY (B)(6) TO HAVE THEM FIXED WITH AN "EXTENDED WARRANTY." I AM CONCERNED THAT THESE WERE ALL DEFECTIVE AND THEY ARE TRYING TO COVER UP THE PROBLEM. REF REPORTS: MW5156403, MW5156404.