BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

    MDR report key: 14955524 · Received July 8, 2022

    Report

    Report Number
    14955524
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    May 5, 2022
    Report Date
    June 24, 2022
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS BROUGHT TO ER (EMERGENCY ROOM) X-RAY ROOM FOR SHUNT SERIES X-RAYS. AFTER INITIAL ANTEROPOSTERIOR SKULL WAS OBTAINED IN THE TABLE BUCKY, THE PLATE WAS TURNED CROSSWISE FOR THE LATERAL SKULL. THE EQUIPMENT THEN FROZE AND COULD NOT TAKE ANY EXPOSURES OR CLICK ANYWHERE ON THE SCREEN. AFTER A COUPLE OF MINUTES OF NOT BEING ABLE TO DO ANYTHING FURTHER, TURNED THE BUCKY BACK TO LENGTHWISE. WERE EVENTUALLY ABLE TO COMPLETE THE EXAM, BUT NEEDED TO TAKE 3 ADDITIONAL IMAGES TO INCLUDE ALL ANATOMY NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2845609 SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED JAA GE MEDICAL SYSTEMS 610402ER1

    Patients

    Seq Age Sex Outcome Treatment
    1 15695 DA Male