BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100

    MDR report key: 6013552 · Received October 10, 2016

    Report

    Report Number
    9616389-2016-00007
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    September 22, 2016
    Report Date
    September 22, 2016
    Manufacturer
    AGFA HEALTHCARE N.V.
    Product Code
    IZL
    PMA / PMN Number
    K103597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON SEPTEMBER 22, 2016, A CUSTOMER REPORTED AN EVENT OF UNINTENDED MOVEMENT WITH ONE DX-D100 MOBILE X-RAY UNIT. WHILE THE CUSTOMER WAS USING THE UNIT, THE UNIT WOULD NOT STOP WHEN THE HANDLE WAS RELEASED. AGFA SERVICE DETERMINED THE ROOT CAUSE AS AN ENGINEER ERROR. THE DEAD MAN SWITCH WAS REPLACED ON (B)(6) 2016 AND WAS NOT TIGHTENED DOWN CORRECTLY AND WOULD CAUSE AN INTERMITTENT STICKING OF THE SWITCH. ON (B)(6) 2016, AGFA SERVICE CLEANED THE MICRO SWITCH, ALIGNED THE DEAD MAN HANDLE ON THE ARM, AND ADJUSTED AND REMOUNTED THE PANEL CARRIER ASSEMBLY. THE UNIT IS NOW WORKING AS INTENDED AND THERE ARE NO NEW REPORTS OF UNINTENDED MOVEMENT. THE SERVICE ENGINEER MUST BE RE-TRAINED WHO DID THE FIRST REPAIR. THERE HAS BEEN NO REPORTED HARM TO PATIENT OR USER DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666705 DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 DX-D 100 MOBILE IZL AGFA HEALTHCARE N.V. DX-D100 MOBILE

    Patients

    Seq Age Sex Outcome Treatment
    1