BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLETRON

    MDR report key: 116851 · Received September 2, 1997

    Report

    Report Number
    MW1011993
    Event Type
    Malfunction
    Date Received
    September 2, 1997
    Date of Event
    May 22, 1997
    Report Date
    September 2, 1997
    Manufacturer
    NUCLETRON CORP.
    Product Code
    JAQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    MICROSELECTRON IS A COMPUTER GUIDANCE INSTRUMENT USED AS A RADIATION TREATMENT DEVICE. THIS DEVICE HAS SPECIFIC COMPUTER INFO THAT IS TRANSFERRED INTO THE CONTROLLER BY THE USE OF A DATA CARD. WHEN THE FACILITY PLACED THE DATA CARD FOR A PT, THE CONTROLLER HAD A READING PROBLEM. INSTEAD OF READING A RADIATION OF 5032 SEC IT WAS READING A RADIATION OF 5476 SEC. PT WAS NOT INJURED BECAUSE THE PROBLEM WAS FOUND BEFORE TREATMENT. FACILITY CONSIDERS THIS EVENT TO BE A PRODUCT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLETRON MICROSELECTRON HIGH DOSE RATE REMOTE AFTER LOADER JAQ NUCLETRON CORP. HDR MICROSELECTRON UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA