BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6600

    MDR report key: 2934262 · Received January 7, 2013

    Report

    Report Number
    1720753-2013-00267
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 7, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE AT MOTHERBOARD. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY WOULD NOT FLUORO. THIS WOULD RESULT IN NO LIVE IMAGE BEING DISPLAYED. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8394 6600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6600

    Patients

    Seq Age Sex Outcome Treatment
    1