BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100

    MDR report key: 11756722 · Received April 30, 2021

    Report

    Report Number
    3001556265-2021-00002
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    February 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
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 2 MALFUNCTION EVENT. THE CUSTOMER REPORTED TWO EVENTS OF UNINTENDED MOVMENT OF A DX-D 100 SYSTEM. THE CUSTOMER DESCRIBED THE SYSTEM DROVE INTO A WALL AND WAS SHUT DOWN BY THE USER. AFTER THE SYSTEM WAS REBOOTED THE DX-D 100 AGAIN EXPERIENCED AN UNINTENDED MOVEMENT AND DROVE INTO THE WALL. AGFA SERVICE RESPONDED ONSITE AND CONFIRMED THE DEADMAN BAR WAS PHYSICALLY BROKEN. THE BROKEN BAR ALLOWED THE MICROSWITCH TO BE COATED IN STICKY MATERIAL, CAUSING A DELAYED OPENING OF THE MICROSWITCH. AGFA SERVICE REPLACED THE BROKEN DEADMAN BAR, REPLACED THE DMC BOARD, AND LATER REPLACED THE SYSTEM HANDGRIPS, WHICH MAY HAVE BEEN DAMAGED DUE TO OVERUSE. THE SYSTEM WAS TESTED AND IS PERFORMING AS INTENDED AND NO ADDITIONAL EVENTS HAVE BEEN REPORTED. 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
    654412 DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 DX-D 100 MOBILE IZL AGFA N.V.

    Patients

    Seq Age Sex Outcome Treatment
    1