BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 873563 · Received June 29, 2007

    Report

    Report Number
    1720753-2007-02774
    Event Type
    Malfunction
    Date Received
    June 29, 2007
    Date of Event
    June 6, 2007
    Report Date
    June 29, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GEHC SERVICE PERSONNEL CHECKED SYSTEM OUTPUT DOSE WHICH WAS 7.97 R/MIN INDICATING SYSTEM OUTPUT IS WITHIN SPECS. DOWNLOADED SYSTEM ERROR LOGS AND FOUND NO INDICATION OF THE DARK IMAGE OCCURENCE. INFORMED CUSTOMER THE CAUSE OF THE INTERMITTENT DARK IMAGE MAY BE POSSIBLE FAULTY PS2 POWER SUPPLY IN MAINFRAME. IN-HOUSE BIOMED WILL ORDER AND REPLACE PS2. IN-HOUSE BIOMED DECIDED ON 6-6-07 TO REQUEST WE REPLACE PWR SUPPLY. ORDERED AND REPLACED PWR SUPPLY ON 6-7-07, PERFORMED SEVERAL FLUORO SEQUENCES WITH NO IMAGE PROBLEMS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DURING A ANGIO CASE THE LEFT MONITOR WENT BLACK DURING FLUORO. THE SYSTEM WAS REBOOTED AND THE CASE WAS COMPLETED. NO PATIENT HARM DUE TO OCCURENCE.

    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 YR