BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGFA DR 800

    MDR report key: 19557875 · Received June 18, 2024

    Report

    Report Number
    3001556265-2024-00002
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    March 22, 2024
    Report Date
    June 18, 2024
    Manufacturer
    AGFA N.V.
    Product Code
    JAA
    PMA / PMN Number
    K183275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A CUSTOMER IN POLAND REPORTED THE SPRING PACKAGE CAME OUT FROM THE TABLE ELEVATING SYSTEM IN AN AGFA DR 800. THERE WERE NO PATIENTS INVOLVED. ONE OF THE ACTUATORS FIRED AND ONE OF THE WALL CHANNELS WAS DAMAGED. INVESTIGATION BY AGFA THE SUPPLIER DETERMINED A HARDWARE ISSUE. THE FRONT LEVER ASSEMBLY WAS REPLACED INCLUDING THE REPLACEMENT OF THE FRONTAL CHAIN RENEWAL AND ALL ITS COMPONENTS. THE CAMERA WAS REPAIRED AND THE CAMERA DRIVER FIRMWARE UPDATED. THE TABLE SETTINGS WERE CALIBRATED AND THE SYSTEM IS WORKING AS INTENDED. THE SUPPLIER DETERMINED THE FRONT LEVER CHAIN OF THE DEVICE MIGHT PRESENT A REDUCTION IN ITS RELIABILITY OVER TIME. THERE COULD BE SEVERAL CONTRIBUTING FACTORS INCLUDING LACK OF OR INSUFFICIENT MAINTENANCE OF THE DEVICE. THERE HAS BEEN NO REPORTED HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2323434 AGFA DR 800 DR 800 JAA AGFA N.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown