BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 4152379 · Received October 3, 2014

    Report

    Report Number
    1720753-2014-08398
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 15, 2014
    Report Date
    October 3, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HIGH VOLTAGE (HV) CABLE WAS EVALUATED AND REPLACED. A FULL GENERATOR AND FILAMENT CALIBRATION WAS PERFORMED AS PART OF THE SERVICE EVENT. 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 LOST WHEN THE SYSTEM WAS ROTATED TO THE LATERAL POSITION. THIS ISSUE WILL EFFECTIVELY ELIMINATE THE ABILITY TO VIEW A REAL TIME IMAGE. NO PT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617700 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

    Patients

    Seq Age Sex Outcome Treatment
    1