BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOCUS

    MDR report key: 352365 · Received September 18, 2001

    Report

    Report Number
    1937649-2001-00005
    Event Type
    Malfunction
    Date Received
    September 18, 2001
    Date of Event
    August 13, 2001
    Report Date
    September 17, 2001
    Manufacturer
    COMPUTERIZED MEDICAL SYSTEMS
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    A USER REPORTED THAT, WHILE RUNNING RELEASE 3.0 SOFTWARE ON THE CO'S FOCUS RTP SYSTEM, HE NOTED THAT THE VALVE USED FOR TXR0 DID NOT CHANGE WHEN USER CHANGED MACHINES, ENERGIES OR PATIENTS. THIS HAPPENED 0NLY IN IRREGULAR FIELD POINT DOSE CALCULATIONS USING THE CLARKSON ALGORITHM. THE PROBLEM WAS OBVIOUS AND NO PATIENTS WERE TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42675 FOCUS RADIATION TREATMENT PLANNING SYSTEM MUJ COMPUTERIZED MEDICAL SYSTEMS ALL RELEASE 3.0

    Patients

    Seq Age Sex Outcome Treatment
    1 *