BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLETRON

    MDR report key: 122282 · Received September 23, 1997

    Report

    Report Number
    1121753-1997-00023
    Event Type
    Malfunction
    Date Received
    September 23, 1997
    Date of Event
    April 4, 1996
    Report Date
    September 23, 1997
    Manufacturer
    NUCLETRON BV
    Product Code
    IWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    FIELD HAD BEEN TREATED WITHOUT A WEDGE ON A CO-60 UNIT. SUBSEQUENTLY FIELD B WAS TRANSFERRED TO A LINEAR ACCELERATOR AND A WEDGE WAS ADDED TO THIS FIELD. BEFORE FIRST TREATMENT WITH LINE W/ACCELERATOR, THE CURRENT REFERENCES SHOWED A BLANK FOR WEDGE MU BUT IT WAS VISIBLE ON THE EDIT FIELD SCREEN. FIRST TREATMENT ON LINE W/ACCELERATOR WAS ACCOMPLISHED SUCCESSFULLY. AFTER FIRST TREATMENT CURRENT REFERENCE SHOWED "O" FOR WEDGE MU ALTHOUGH WEDGE MU WAS DELIVERED. AT SECOND TREATMENT ON THE LINE W/ACCELERATOR, NO SETUP FOR WEDGE WAS DISPLAYED (WHICH WAS INCORRECT); TOTAL DOSE WAS DELIVERED WITHOUT WEDGE, BUT DOSE ACCUMULATION WAS WRONG AS IF THE ORIGINAL DOSE WITHOUT WEDGE HAD BEEN GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLETRON VERIFLEX R & V SYSTEM IWB NUCLETRON BV V2.03A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other