BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 3210021 · Received July 3, 2013

    Report

    Report Number
    1720753-2013-07854
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 3, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SVC REP FORMED AN OVER-THE-PHONE INVESTIGATION. THE CUSTOMER HAS OPTED TO ORDER THE PARTS AND PERFORM THE REPAIRS THEMSELVES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LEFT MONITOR WOULD NOT DISPLAY AN IMAGE. THIS RESULTED IN A LOSS OF THE LIVE IMAGE. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303979 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1