BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS GEMINI DUAL PET/CT SCANNER

    MDR report key: 1208783 · Received October 21, 2008

    Report

    Report Number
    MW5008697
    Event Type
    Death
    Date Received
    October 21, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 21, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS CLEVELAND, INC.
    Product Code
    KPS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OUTPATIENT WAS AMBULATORY, ALERT, AND COGNIZANT. ESCORTED BY TECHNOLOGIST TO THE SCANNING AREA. PATIENT AND TECHNOLOGIST (APPROX 18-24 INCHES APART) ON THE SAME SIDE OF THE BED, BED AT LOWEST LEVEL (24 INCHES FROM FLOOR), PATIENT TURNED TO SIT ON BED, WAS ASKED TO PLACE HEAD TOWARDS GANTRY. PATIENT TURNED LEGS TO COMPLY AND SLID OFF EDGE, FELL TO THE FLOOR IN AN UPRIGHT, SITTING POSITION. THE SCANNING BED DESIGN HAS A FIXED, CURVED EDGE, COMPOSED OF PLASTIC TYPE MATERIAL THAT IS 8 INCHES WIDE AND SLOPES TOWARDS THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS GEMINI DUAL PET/CT SCANNER PET/CT KPS PHILIPS MEDICAL SYSTEMS CLEVELAND, INC. 453567900871 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death