BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOCUS

    MDR report key: 403384 · Received June 28, 2002

    Report

    Report Number
    1937649-2002-00015
    Event Type
    Malfunction
    Date Received
    June 28, 2002
    Date of Event
    May 17, 2002
    Report Date
    June 28, 2002
    Manufacturer
    COMPUTERIZED MEDICAL SYSTEMS
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THEIR FOCUS RTP SYSTEM WAS PROVIDING INCORRECT MONITOR UNIT CALCULATIONS WHEN THEY USED A TPR-BASED PHOTON MACHINE FOR WHICH THEY HAD ALSO ENTERED BSF VALUES. NO PATIENTS WERE TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOCUS RADIATION TREATMENT PLANNING SYS MUJ COMPUTERIZED MEDICAL SYSTEMS 9200 RELEASE 3.2.1

    Patients

    Seq Age Sex Outcome Treatment
    1 *