BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2934154 · Received January 3, 2013

    Report

    Report Number
    1720753-2013-00084
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 3, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE HIGH VOLTAGE CABLE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE IMAGE QUALITY OF THE IMAGES PRODUCED WAS DEGRADED TO A POINT IN WHICH THEY WERE NOT USABLE AND WOULD BE SERIOUS IF IT WERE TO RECUR. THE SYSTEM WAS REMOVED FROM THE PATIENT CASE. IT COULD OR DID RESULT IN THE TERMINATION AND/OR RESCHEDULING OF AN INTERVENTIONAL PROCEDURE. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3824 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1