BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTREAM 2400P

    MDR report key: 19582851 · Received June 20, 2024

    Report

    Report Number
    MW5156404
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Date of Event
    June 7, 2024
    Report Date
    June 14, 2024
    Manufacturer
    NANORAY CO., LTD.
    Product Code
    EHD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 8/7/2024 FOR REPORT MW5156404 TO UPDATE THE MANUFACTURER TO NANORAY CO. LTD.

    Description of Event or Problem · 0

    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, MW5156405.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604594 CARESTREAM 2400P UNIT, X-RAY, EXTRAORAL WITH TIMER EHD NANORAY CO., LTD. NRF-350-G1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown