BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3802165 · Received December 30, 2013

    Report

    Report Number
    1720753-2013-13860
    Event Type
    Malfunction
    Date Received
    December 30, 2013
    Date of Event
    December 11, 2013
    Report Date
    December 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. ONSITE INVESTIGATION REVEALED THAT NO CAUSE COULD BE DETERMINED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FLUOROSCOPIC IMAGE WAS INTERMITTENTLY LOST OR BLACK. THIS ISSUE WILL EFFECTIVELY ELIMINATE THE ABILITY TO VIEW A REAL TIME IMAGE. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679805 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1