BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100

    MDR report key: 14255927 · Received April 29, 2022

    Report

    Report Number
    3001556265-2022-00001
    Event Type
    Malfunction
    Date Received
    April 29, 2022
    Date of Event
    February 21, 2022
    Report Date
    April 29, 2022
    Manufacturer
    AGFA N.V.
    Product Code
    IZL
    PMA / PMN Number
    K103597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. THE CUSTOMER REPORTED AN EVENT OF UNINTENDED MOVEMENT OF A DX-D 100 SYSTEM. THE CUSTOMER REPORTED WHEN PRESSING ONLY THE LEFT HANDGRIP THE SYSTEM WAS SLOWER IN COMPARISION THEN WHEN THE RIGHT HANDGRIP WAS PRESSED. IT WAS ALSO REPORTED THE SYSTEM WAS DRIVING FAST AND DROVE AGAINST THE ELEVATOR WALL. AGFA SERVICE RESPONDED ONSITE AND INSPECTED THE DX-D 100 SYSTEM. DURING THE SYSTEM TEST, THE LOCAL SERVICE ENGINEER CONFIRMED A HARDWARE FAILURE. AGFA SERVICE REPLACED THE DMC-BOARD, ATP BOARD, AND ADJUSTED THE GAUGES. THE SYSTEM WAS TESTED AND WORKED AS INTENDED. THERE HAVE BEEN NO REPORTS OF ADDITIONAL EVENTS. THERE WAS NO REPORTED HARM TO PATIENTS OR USERS AND THERE ARE NO ADDITIONAL ACTIONS FOR THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290198 DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 DX-D 100 MOBILE IZL AGFA N.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male