BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3172229 · Received June 5, 2013

    Report

    Report Number
    1720753-2013-06761
    Event Type
    Malfunction
    Date Received
    June 5, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 5, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE PS3 POWER SUPPLY VOLTAGE WAS ADJUSTED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE LEFT MONITOR WAS FLICKERING AND THEN WENT GRAY. THIS RENDERED THE SYSTEM UNUSABLE DUE TO THE LOSS OF THE LIVE IMAGE. THERE IS NO REPORT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249185 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1