BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGIQ BOOK ULTRASOUND SCANNER DIAGNOSTIC W/O AC/DC CORD

    MDR report key: 820524 · Received February 12, 2007

    Report

    Report Number
    820524
    Event Type
    Malfunction
    Date Received
    February 12, 2007
    Date of Event
    January 10, 2007
    Report Date
    February 12, 2007
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    A LOGIQ COMPACT ULTRASOUND SYSTEM WAS BEING RECHARGED AND OVERHEATED AT THE MACHINE'S PLUG-IN, THUS MELTING THE CORD AT THIS POINT. THE FIRE CREATED AN ELECTRICAL ODOR AND HAZE IN THE ROOM. THE MACHINE WAS NOT BEING USED ON A PATIENT WHEN THE FIRE OCCURRED. BIO-TECH EXAMINED THE UNIT, WHICH WAS BURNED AT THE PLUG-IN. THE UNIT WAS SENT TO GE FOR REPAIR OF A DEFECTIVE AC/DC CORD AND REPAIR OF THE POWER SOCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOGIQ BOOK ULTRASOUND SCANNER DIAGNOSTIC W/O AC/DC CORD SCANNER, ULTRASOUND ITX GE MEDICAL SYSTEMS, LLC LBAC-66 *
    2 AC/DC POWER CORD POWER CORD ITX GE MEDICAL SYSTEMS, LLC LBAC-66 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *