BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 874636 · Received July 4, 2007

    Report

    Report Number
    1720753-2007-02997
    Event Type
    Malfunction
    Date Received
    July 4, 2007
    Date of Event
    June 12, 2007
    Report Date
    July 4, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GEHC SERVICE PERSONNEL FOUND 5V AT ALL APPLICABLE TEST POINTS. REPLACED CONTROL PANEL PCB AND FFB. ADJUSTED PS2 FOR 5V ON FFB. CTRL PNL AT 5V. SYSTEM IS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED MAINFRAME HAS ALL SQUARES ON DISPLAY; WORKSTATION IS OK.

    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