BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 2934258 · Received January 7, 2013

    Report

    Report Number
    1720753-2013-00255
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 7, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT (LIVE) MONITOR WAS NOT WORKING. THIS WILL CAUSE THE SYSTEM TO BE UNUSABLE DUE TO A LOSS OF THE LIVE IMAGE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8460 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9800

    Patients

    Seq Age Sex Outcome Treatment
    1