BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2943148 · Received January 21, 2013

    Report

    Report Number
    1720753-2013-00866
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 21, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND COULD NOT PRODUCE THE REPORTED PROBLEM. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WOULD NOT DISPLAY AN IMAGE ON THE LEFT MONITOR. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28997 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1