BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUOROSCOPIC X-RAY

    MDR report key: 891615 · Received August 9, 2007

    Report

    Report Number
    1720753-2007-03945
    Event Type
    Malfunction
    Date Received
    August 9, 2007
    Date of Event
    July 3, 2007
    Report Date
    August 9, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 AND TECHNIQUE PROCESSOR BOARDS. BOARDS SENT FOR REPAIR. FOLLOW-UP VISIT REQUIRED TO REPLACE. ADDITIONAL INFORMATION WILL BE PROVIDED AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9600 SYSTEM DID NOT BOOT UP AND THE MAINFRAME DISPLAYED A "IFB ERROR". NO PATIENT INJURY WAS REPORTED.

    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