BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 4102901 · Received September 19, 2014

    Report

    Report Number
    1644487-2014-02405
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE PRACTITIONER'S HANDHELD WAS NOT HOLDING A CHARGE, NOR WOULD THE SCREEN RESPOND AFTER A HARD RESET. TROUBLESHOOTING WAS PERFORMED BY CONFIRMING THAT THE HARD RESET WAS PERFORMED CORRECTLY AND THE SCREEN WAS CLEANED, THE BATTERY WAS REMOVED AND REINSERTED AND THE SCREEN LOCK WAS CONFIRMED TO NOT BE ENGAGED. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUES. THE NURSE PRACTITIONER WAS PROVIDED A NEW PROGRAMMING TABLET AND THE HANDHELD WAS RECEIVED FOR ANALYSIS. ANALYSIS IS UNDERWAY, BUT HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED HANDHELD DEVICE AND SOFTWARE FLASHCARD WAS COMPLETED. IT WAS IDENTIFIED THAT THE HANDHELD WAS UNABLE TO ADVANCE PAST THE WELCOME SCREEN. THE CAUSE FOR THE DISPLAY ANOMALY IS ASSOCIATED WITH RESISTANCE VALUES BEING HIGHER THAN EXPECTED IN THE TOUCH SCREEN CIRCUITRY. NO ANOMALIES ASSOCIATED WITH THE MAIN BATTERY WERE IDENTIFIED DURING THE ANALYSIS. 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
    584565 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1075226

    Patients

    Seq Age Sex Outcome Treatment
    1