BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100

    MDR report key: 11758080 · Received April 30, 2021

    Report

    Report Number
    3001556265-2021-00004
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    April 8, 2021
    Report Date
    April 30, 2021
    Manufacturer
    AGFA N.V.
    Product Code
    IZL
    PMA / PMN Number
    K103597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT. THE CUSTOMER REPORTED AN EVENT OF UNINTENDED MOVMENT OF A DX-D 100 SYSTEM. THE CUSTOMER DESCRIBED THE SYSTEM WAS DRIVING ERRATICALLY. THE RESPONDING SERVICE DEALER ENGINEER STATED THE CUSTOMER REPORTED THE DX-D 100 SYSTEM WOULD SPEED UP AND THEN TURN SHARPLY BEFORE STOPPING. THE DX-D 100 CONTINUED WHEN THE DEAD MAN SWITCH WAS NOT ENGAGED. THERE WERE NO REPORTED ERROR CODES OR BEEPS FROM THE SYSTEM. THE DEALER SERVICE ENGINEER CHECKED AND ADJUSTED THE DRIVE GAUGES AS PER THE SERVICE MANUAL. THEN ENGINEER ALSO REPLACED THE GAUGES, DEADMAN SWITCHES, AND DMC BOARD. AFTER A SYSTEM CHECK THE ISSUE REOCCURED. THE DEALER SERVICE ENGINEER THEN REPLACED THE MOTORS AND ENCODER CABLES. THE SYSTEM WAS TESTED AND IS PERFORMING 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
    654421 DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 DX-D 100 MOBILE IZL AGFA N.V.

    Patients

    Seq Age Sex Outcome Treatment
    1