BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROSCOPIC X-RAY

    MDR report key: 891629 · Received August 9, 2007

    Report

    Report Number
    1225258-2007-00071
    Event Type
    Malfunction
    Date Received
    August 9, 2007
    Date of Event
    July 1, 2007
    Report Date
    August 9, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. IDENTIFIED THE NEED TO REPLACE THE IFB (UNIVERSAL INTERFACE) BOARD. THE IFB WAS REPLACED AND THE SYSTEM FUNCTIONED AS INTENDED. SYSTEM WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ITRAK 3500P SYSTEM DOES NOT RECOGNIZE THAT TRANSMITTER/RECEIVER ARE PRESENT. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. ITRAK 3500P NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR