BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRX REVOLUTION NANO MOBILE X-RAY SYSTEM

    MDR report key: 11957291 · Received June 8, 2021

    Report

    Report Number
    11957291
    Event Type
    Malfunction
    Date Received
    June 8, 2021
    Date of Event
    May 18, 2021
    Report Date
    May 25, 2021
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    X-RAY EXAM ORDERED FOR PATIENT. WHEN PATIENT INFORMATION WAS PULLED UP ON THE MAIN SCREEN OF THE CARESTREAM DRX-REVOLUTION NANO MOBILE X-RAY SYSTEM, THE DEVICE PULLED UP A DIFFERENT PATIENTS INFORMATION ON THE TUBE SCREEN. WHEN THIS DEVICE MALFUNCTION OCCURS, IF THE TECH DOES NOT CATCH THE ISSUE, THE X-RAY SHOWS TWO DIFFERENT NAMES (ONE CORRECT, ONE INCORRECT), AND THE IMAGES WILL GO UNDER THE INCORRECT PATIENT. IN THIS INCIDENCE, THE ERROR WAS CAUGHT. THE MACHINE WAS NOT USED FOR THIS EXAM. PORTABLE X-RAY MACHINE, DRX REVOLUTION - SOFTWARE VERSION 10.0.14393.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855882 DRX REVOLUTION NANO MOBILE X-RAY SYSTEM SYSTEM, X-RAY, MOBILE IZL CARESTREAM HEALTH, INC. DRXR-1

    Patients

    Seq Age Sex Outcome Treatment
    1