BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1890869 · Received October 28, 2010

    Report

    Report Number
    1890869
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 28, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE THE PHYSICIAN WAS BEGINNING A RETROGRADE PERCUTANEOUS GASTROSTOMY PROCEDURE, THE C-ARM FAILED TO PRODUCE AN IMAGE. THE SYSTEM WAS TURNED OFF AND REBOOTED, AND AGAIN IT FAILED TO PRODUCE AN IMAGE. THE C-ARM WAS WITHDRAWN AND ANOTHER C-ARM BROUGHT INTO ITS PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * X-RAY SYSTEM, PORTABLE C-ARM JAA GE OEC MEDICAL SYSTEMS 9800 *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR