BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3960200 · Received June 24, 2014

    Report

    Report Number
    1720753-2014-05404
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 23, 2014
    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 SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE IMAGE PROCESSOR PCB, DISPLAY ADAPTER PCB AND VIDEO CONTROLLER PCB ASSEMBLIES WERE EVALUATED AND RESEATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FLUOROSCOPIC IMAGE WAS SCATTERED AND SCRAMBLED ON BOTH MONITORS EFFECTIVELY ELIMINATING THE ABILITY TO VIEW A USABLE IMAGE. NO PATIENT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367522 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1