BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEC 9800 12 STANDAR

    MDR report key: 1785143 · Received August 3, 2010

    Report

    Report Number
    1720753-2010-02277
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    June 4, 2010
    Report Date
    August 3, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED A CABLE CONNECTING THE FOOTSWITCH INTERFACE BOARD TO THE FLUOROFUNCTIONS BOARD (INFORMATION DERIVED FROM PART NUMBER PROVIDED BY FSE). SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, THE SYSTEM WILL NOT PRODUCE X-RAYS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OEC 9800 12 STANDAR FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1