BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE HEALTHCARE PORTABLE C XRAY MACHINE

    MDR report key: 16386493 · Received February 15, 2023

    Report

    Report Number
    MW5114982
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Date of Event
    February 9, 2023
    Report Date
    February 13, 2023
    Manufacturer
    GE MEDICAL SYSTEMS, LLC.
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A PORTABLE CHEST X-RAY EXAM, THE TUBE HEAD FREE FLOATED AND CAME DOWN TOWARDS THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359271 GE HEALTHCARE PORTABLE C XRAY MACHINE SYSTEM, X-RAY, MOBILE IZL GE MEDICAL SYSTEMS, LLC. OPTIMA XR 220 AMX

    Patients

    Seq Age Sex Outcome Treatment
    1 17 MO Male