BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROSCOPIC X-RAY

    MDR report key: 931809 · Received October 24, 2007

    Report

    Report Number
    1720753-2007-06915
    Event Type
    Malfunction
    Date Received
    October 24, 2007
    Date of Event
    October 2, 2007
    Report Date
    October 24, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. THE SYSTEM WAS WORKING AS INTENDED AS VERIFIED BY THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BAD IROS ERROR WAS DISPLAYED ON THE 9600+ SYSTEM. SYSTEM WAS REBOOTED AND THE ERROR CLEARED. THE CASE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 9600+ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR