BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DXD-525 RAD

    MDR report key: 437728 · Received January 10, 2003

    Report

    Report Number
    2126677-2003-00001
    Event Type
    Malfunction
    Date Received
    January 10, 2003
    Date of Event
    December 4, 2002
    Report Date
    January 10, 2003
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    IZO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A TECHNOLOGIST WAS SHOCKED BY THE KVP SELECTOR SWITCH DURING AN EXPOSURE. THE TECHNOLOGIST SAW A DOCTOR THAT AFTERNOON AND WAS SORE DURING THE FOLLOWING DAY BUT NO OTHER INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXD-525 RAD DIAGNOSTIC X-RAY IZO GE MEDICAL SYSTEMS 2349926 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other