BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALCYON I

    MDR report key: 44673 · Received September 30, 1996

    Report

    Report Number
    2126677-1996-00008
    Event Type
    Malfunction
    Date Received
    September 30, 1996
    Date of Event
    August 23, 1996
    Report Date
    September 30, 1996
    Manufacturer
    GE MEDICAL SYSTEMS EUROPE
    Product Code
    IWB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE GANTRY ROTATED UNEXPECTEDLY AND STRUCK THE UNDERSIDE OF THE PT TABLE. A PT WAS ON THE TABLE BUT WAS NOT INJURED. INVESTIGATION INDICATED THAT GANTRY ROTATION WAS DUE TO A SHORT BETWEEN TWO WIRES IN THE GANTRY HAND-HELD CONTROL BOX (CONTROL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCYON I RADIO-THERAPY IWB GE MEDICAL SYSTEMS EUROPE 2118660 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN
    2