BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1021750 · Received March 19, 2008

    Report

    Report Number
    1720753-2008-19777
    Event Type
    Malfunction
    Date Received
    March 19, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 18, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE MALFUNCTION WAS VERIFIED. RESET THE TRANSFORMER FOR CORRECT VOLTAGE OUT AND ADJUSTED THE 5VDC IN MAINFRAME. ADJUSTED THE COLLIMATOR. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 9800 SYSTEM INTERMITTENTLY IS LOCKING UP. IT WAS NOTED THAT THE COLLIMATOR IS CLOSING DOWN, AND THE LIVE INDICATOR IS FLASHING ON THE LEFT MONITOR. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 9800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK