BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET

    MDR report key: 44678 · Received September 30, 1996

    Report

    Report Number
    2126677-1996-00010
    Event Type
    Malfunction
    Date Received
    September 30, 1996
    Date of Event
    August 26, 1996
    Report Date
    September 30, 1996
    Manufacturer
    GE MEIDCAL SYSTEMS EUROPE
    Product Code
    KPQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IF THE USER ENTERS AN IMPROPER KEYBOARD SEQUENCE INTO THE RADIO-THERAPY PLANNING SYSTEM WHEN SWITCHING FROM ONE TREATMENT DEVICE TO ANOTHER, THE RESULTING TREATMENT PLAN COULD RESULT IN ERROR. THERE HAVE BEEN NO REPORTS OF IMPROPER THERAPY TREATMENTS DUE TO THIS USER ERROR. INSTRUCTIONS FOR PROPER USE ARE GIVEN IN THE USER MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET THERAPY PLANNING KPQ GE MEIDCAL SYSTEMS EUROPE S2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA