BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUILION-32

    MDR report key: 1902873 · Received September 30, 2010

    Report

    Report Number
    1902873
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Date of Event
    July 16, 2010
    Report Date
    September 23, 2010
    Manufacturer
    TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PRESSED 'SCAN' TO TAKE IMAGES BUT CT SCANNER FROZE WITHOUT ANY APPARENT REASON. ATTEMPTED EVERY STEP TO MAKE IT WORK, BUT UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUILION-32 CT SCANNER JAK TOSHIBA AMERICA MEDICAL SYSTEMS, INC. AQUILION-32 *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR