BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 4182122 · Received October 17, 2014

    Report

    Report Number
    1644487-2014-02746
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 23, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN¿S HANDHELD DEVICE WAS NOT WORKING AND THE SCREEN WAS BLACK DESPITE BEING FULLY CHARGED. A HARD RESET WAS PERFORMED BUT THE ISSUE DID NOT RESOLVE. THE BLACK SCREEN ALLEGATION WAS NOT DUPLICATED BUT IT WAS NOTED THAT HANDHELD SCREEN WAS UNRESPONSIVE. THE HANDHELD DEVICE AND SOFTWARE FLASHCARD HAVE BEEN RETURNED TO THE MANUFACTURER WHERE ANALYSIS IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    ANALYSIS OF THE HANDHELD WAS COMPLETED ON 10/30/2014. NO ANOMALIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT WERE IDENTIFIED DURING THE ANALYSIS. DURING THE ANALYSIS IT WAS IDENTIFIED THAT THE HANDHELD WAS UNABLE TO ADVANCE PAST THE SCREEN ALIGNMENT UTILITY. THE CAUSE FOR THE DISPLAY ANOMALY IS ASSOCIATED WITH RESISTANCE VALUES BEING HIGHER THAN EXPECTED IN THE TOUCH SCREEN CIRCUITRY. NO FURTHER ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE IDENTIFIED DURING THE ANALYSIS. ANALYSIS OF THE SOFTWARE WAS COMPLETED ON 10/30/2014. 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
    660934 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1063528

    Patients

    Seq Age Sex Outcome Treatment
    1