BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1206544 · Received October 23, 2008

    Report

    Report Number
    1720753-2008-25551
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    August 20, 2008
    Report Date
    September 5, 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

    Additional Manufacturer Narrative · 1

    THE GE SERVICE REP FOUND THE SYSTEM WILL LOCK UP AFTER A FEW SECONDS OF SUBTRACTION. CABLES ON CINE BRIDGE BOARD SEEMED TWISTED. ORDER PARTS. THE GE REO REMOVED AND REPLACED THE PARTS. THE SYSTEM IS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM HANGS UP ON SUBTRACTION MODE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1