BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1963687 · Received December 21, 2010

    Report

    Report Number
    1644487-2010-02862
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN'S DELL X5 HANDHELD DEVICE WAS NOT FUNCTIONING PROPERLY. THE SCREEN WAS BLANK (WHITE) AND THEN WOULD PROCEED TO THE MAIN WINDOWS SCREEN. THE PHYSICIAN WAS INSTRUCTED TO PERFORM A HARD RESET. HE THEN NAVIGATED THROUGH THE TUTORIALS AND EVENTUALLY OBTAINED A SCREEN STATING "VNS SOFTWARE IS LOADING" HOWEVER THIS SCREEN THEN WENT BLANK. THE SOFTWARE ATTEMPTED TO LOAD AGAIN HOWEVER THE SCREEN WHEN BLANK AGAIN. A REPLACEMENT HANDHELD HAS BEEN SENT TO THE PHYSICIAN AND THE DELL X5 IN QUESTION HAS BEEN RETURNED TO THE MFR. PRODUCT ANALYSIS IS IN PROCESS AND HAS NOT BEEN COMPLETED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE MUZ CYBERONICS, INC. 250 544025

    Patients

    Seq Age Sex Outcome Treatment
    1