BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAVELIN 3.2.0 (CONTROLS SYSTEM)SL SERIES

    MDR report key: 545601 · Received April 1, 2004

    Report

    Report Number
    9617016-2004-00006
    Event Type
    Malfunction
    Date Received
    April 1, 2004
    Date of Event
    February 27, 2004
    Report Date
    April 1, 2004
    Manufacturer
    ELEKTA LIMITED
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    UNUSUAL MACHINE BEHAVIOR WAS NOT HIGHLIGHTED BY TOLERANCE CHECKING. FOLLOWING TREATMENT OF FIELD 1, IT WOULD APPEAR THAT THE SECOND FILED PRESCRIPTION WAS LOADED CORRECTLY AND DISPLAYED IN THE SET AND RUN COLUMNS. HOWEVER, FOR SOME REASON THE GANTRY AND DIAPHRAM ROTATION REMAINED IN THE FILED 1 POSITION ON THE ACTUAL COLUMN AND WERE NOT TOLERANCE CHECKED, ALLOWING POTENTIAL DELIVERY. THERE WAS NO ADVERSE OUTCOME. TREATMENT NOT DELIVERED WITH THE INCORRECT SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAVELIN 3.2.0 (CONTROLS SYSTEM)SL SERIES DIGITAL LINEAR ACCELERATOR IYE ELEKTA LIMITED JAVELIN 3.2.0 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other