BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEVITRON 74

    MDR report key: 52856 · Received November 25, 1996

    Report

    Report Number
    52856
    Event Type
    Other
    Date Received
    November 25, 1996
    Date of Event
    October 1, 1996
    Report Date
    November 21, 1996
    Manufacturer
    SIEMEN'S MEDICAL SYSTEMS
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT CAME FOR THERAPUTIC RADIATION TREATMENT. DOSAGE RATES SET. STUDENT WAS ABLE TO SET THE MACHINE ON HI ELECTRON MODE WITHOUT WARNING THE OPERATOR THAT THE HIGH ELECTRON DOSAGE WAS ON, PT RECEIVED 2100 CGY, RATHER THAN 300 CGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEVITRON 74 LINEAR THERAPEUTIC RADIATION IYE SIEMEN'S MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other