BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1220624 · Received October 31, 2008

    Report

    Report Number
    9617766-2008-01404
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 28, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP WAS UNABLE TO DUPLICATE THE PROBLEM. THE GENERATOR ERROR CAN BE CREATED BY MONOBLOCK, BATTERIES, THE MONOBLOCK CONTROLLER AND HV CABLE. ALL CHECK IN GOOD OPERATING CONDITION AT TIME OF INSPECTION. THE REP VERIFIED ALL CABLING AND INTERNAL POWER SUPPLIES WERE OPERATIONAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A GENERATOR ERROR. THE STAFF POWERED DOWN AND RESTARTED THE SYSTEM. THE CASE WAS COMPLETED SUCCESSFULLY. NO INJURY TO PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1