BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9600

    MDR report key: 1071117 · Received July 10, 2008

    Report

    Report Number
    1720753-2008-22896
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 25, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A 'REGULATOR FAILED' MESSAGE APPEARED ON MAINFRAME DISPLAY. CUSTOMER THEN TURNED SYSTEM OFF THEN BACK ON. THE DISPLAY THEN SAID 'CHARGER FAILED' AND SYSTEM SMELLED OF SMOKE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1