BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    AGFA DR 400MQ

    MDR report key: 22670830 · Received July 30, 2025

    Report

    Report Number
    3001556265-2025-00002
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    July 9, 2025
    Report Date
    July 30, 2025
    Manufacturer
    AGFA N.V.
    Product Code
    MQB
    UDI-DI
    05414904176252
    PMA / PMN Number
    K141192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A CUSTOMER IN THE US REPORTED THE COLLIMATOR FELL OFF A DR 400 SYSTEM WHILE THE CUSTOMER WAS ROTATING THE COLLIMATOR. THE LOCAL AGFA FIELD SERVICE ENGINEER RESPONDED AND CONFIRMED A PORTION OF THE RESIN FLANGE WAS BROKEN. A NEW COLLIMATOR AND METAL FLANGE WAS INSTALLED. PER THE CUSTOMER REQUEST A SYSTEM PREVENTIVE MAINTENANCE (PM) WAS ALSO PERFORMED. THE SYSTEM IS NOW WORKING AS INTENDED AND THERE HAVE BEEN NO ADDITONAL EVENTS REPORTED. THERE WAS NO REPORTED HARM TO USER OR PATIENTS AND THERE ARE NO FUTURE ACTIONS RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514265 AGFA DR 400MQ DR 400 MQB AGFA N.V. 05414904176252

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown