BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUFIX IMRT HEADBOARD

    MDR report key: 726190 · Received May 30, 2006

    Report

    Report Number
    MW1039374
    Event Type
    Malfunction
    Date Received
    May 30, 2006
    Date of Event
    May 24, 2006
    Report Date
    May 25, 2006
    Manufacturer
    WFR/AGUAPLAST CORP
    Product Code
    KXJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AS THE PT SAT UP, THE STABILIZER ON THE BOARD BROKE AND TILTED PT OFF THE TABLE. ON CHECKING THE BOARD, THE METAL ATTACHMENT TO HOLD IT TO THE TREATMENT TABLE HAD COME OFF (SCREWS WERE STRIPPED). APPROX AGE OF DEVICE: 18 MONTHS. DEVICE USE @ RADIATION THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUFIX IMRT HEADBOARD HEADBOARD KXJ WFR/AGUAPLAST CORP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR