BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE #1 DMLC - DYNAMIC MULTILEAF COLLIMATOR

    MDR report key: 582730 · Received February 25, 2004

    Report

    Report Number
    9617259-2004-00001
    Event Type
    Malfunction
    Date Received
    February 25, 2004
    Date of Event
    February 25, 2004
    Report Date
    February 25, 2004
    Manufacturer
    3D LINE INTL.
    Product Code
    LXL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE REMOVABLE DMLC BASE PLATE WAS NOT SECURED CORRECTLY DURING ITS MOUNTING ONTO THE LINAC. AS A RESULT THE DEVICE FELL FROM THE LINAC DURING GANTRY ROTATION. THIS EVENT INCURRED SOME SUPERFICIAL INJURIES TO THE PATIENT, WHICH WAS POSITIONED ON THE COUCH FOR TREATMENT. THE RESULTING INJURIES WERE EXAMINED BY A CLINICIAN AND WERE NOT CONSIDERED SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEVICE #1 DMLC - DYNAMIC MULTILEAF COLLIMATOR RADIOTHERAPY BEAN BLOCKING DEVICE LXL 3D LINE INTL. 81-1A *

    Patients

    Seq Age Sex Outcome Treatment
    1 *