BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUILION 16

    MDR report key: 1328638 · Received February 19, 2009

    Report

    Report Number
    1328638
    Event Type
    Malfunction
    Date Received
    February 19, 2009
    Date of Event
    February 16, 2009
    Report Date
    February 19, 2009
    Manufacturer
    TOSHIBA AMERICA MEDICAL SYSTEMS
    Product Code
    JAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE INTERVENTIONAL RADIOLOGIST AND THE RADIOLOGY TECH WERE PERFORMING A BIOPSY WHEN THEY NOTICED AN ELECTRICAL SMELL. ONE OR TWO MINUTES LATER THEY HEARD A POPPING NOISE FROM BEHIND THE GANTRY AND SMOKE ROSE TO THE CEILING. THE SCANNER WAS TURNED OFF IMMEDIATELY AND THE PATIENT WAS REMOVED FROM THE AREA. THE PATIENT WAS NOT HARMED. THE FIRE COMPANY AND BIOMEDICAL ENGINEERING WERE CALLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUILION 16 CT SCANNER JAK TOSHIBA AMERICA MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR