BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600EMI

    MDR report key: 870999 · Received June 26, 2007

    Report

    Report Number
    1720753-2007-02624
    Event Type
    Malfunction
    Date Received
    June 26, 2007
    Date of Event
    June 4, 2007
    Report Date
    June 26, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GEHC SVC PERSONNEL ADJUSTED WS FOR +5.1VDC. ADJUSTED CAMERA HOZ. & VERT. CENTER. ADJUSTED FLU REPLACED POWER CABLE. TESTED DC POWER SUPPLY- +5.1VDC, +12.2VDC, -11.9VDC, -4.9VDC. TESTED SYS OPERATION. ALL SVC REPAIRS REQUESTED BY CUSTOMER HAVE BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED NO PT INVOLVEMENT. SYS WAS PURCHASED & INSTALLED BY THIRD PARTY . INTERMITTENT REBOOT AC LINE SAGS INTERMITTENTLY, CUSTOMER WILL NOTIFY LOCAL ELECTRICAL CO. FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9600EMI FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS, INC. 9600EMI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR