BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3201919 · Received July 2, 2013

    Report

    Report Number
    1644487-2013-02013
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE PHYSICIAN¿S HANDHELD HAD FROZEN ON THE ¿INTERROGATION SUCCESSFUL¿ SCREEN. REMOVING THE FLASHCARD UNFROZE THE SCREEN AND A HARD RESET WAS PERFORMED. THE DEVICE RETURNED TO NORMAL FUNCTIONING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S HANDHELD WOULD CONTINUALLY FREEZE ON THE "INTERROGATION SUCCESSFUL" SCREEN. THE PHYSICIAN COMPLETED TROUBLESHOOTING THAT INCLUDED COMPLETING A SOFT AND HARD RESET, RESEATING THE FLASHCARD AND VERIFYING ALL CONNECTIONS WERE GOOD. IT WAS REPORTED THAT THESE TROUBLESHOOTING METHODS DID NOT RESOLVE THE FROZEN SCREEN AND THE PHYSICIAN WAS PROVIDED A NEW PROGRAMMING TABLET. THE HANDHELD WITH THE FREEZING SCREEN WAS RETURNED TO MANUFACTURER FOR ANALYSIS. ANALYSIS OF THE HANDHELD WAS COMPLETED ON (B)(4) 2014. NO ANOMALIES ASSOCIATED WITH THE HANDHELD WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE FLASHCARD ANALYSIS WAS COMPLETED ON (B)(4) 2014. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302772 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 1081704

    Patients

    Seq Age Sex Outcome Treatment
    1