BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-ARM

    MDR report key: 1831902 · Received September 8, 2010

    Report

    Report Number
    9680959-2010-00318
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    July 2, 2010
    Report Date
    September 8, 2010
    Manufacturer
    GE OEC MEDICAL SYSTEMS GMBH
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. NO MALFUNCTION HAS OCCURRED. THE DATA BETWEEN THE WORKSTATION AND THE WORKLIST SERVER NEEDS TO BE EXAMINED BY THE FACILITY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE MONITOR TURNED BLACK AND FAILED TO DISPLAY AN IMAGE. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-ARM FLUOROSCOPY XRAY JAA GE OEC MEDICAL SYSTEMS GMBH 7900

    Patients

    Seq Age Sex Outcome Treatment
    1