BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2810381 · Received October 31, 2012

    Report

    Report Number
    1644487-2012-02817
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 3, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE CAUSED EVENT BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ON (B)(6) 2012, IT WAS REPORTED A PHYSICIAN'S HANDHELD DEVICE WAS STUCK ON THE SCREEN THAT INDICATED "TO CLEAR ALL DATA IN THE MEMORY PRESS" THAT TYPICALLY COMES UP AFTER PERFORMING A HARD RESET. TROUBLESHOOTING WAS PERFORMED FOR 20 MINUTES, BUT THE SCREEN WOULD NOT PROGRESS PAST THAT POINT. IT WAS CONFIRMED THAT THE SCREEN WAS NOT LOCKED, THE BUTTON WAS BEING PRESSED (AND NOT JUST THE SCREEN), AND MULTIPLE HARD RESETS WERE PERFORMED. THE SCREEN WOULD FLASH AS IF IT HAD RESPONDED TO THE HARD RESET, AND THE "TO CLEAR ALL DATA" SCREEN WOULD COME UP EACH TIME; HOWEVER, EVEN WHEN THE MAIL BUTTON WAS PRESSED (THE PROMPT TO CANCEL THE OPERATION), NOTHING HAPPENED. ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    THE HANDHELD DEVICE AND SOFTWARE FLASHCARD WERE RETURNED ON (B)(6) 2012. PRODUCT ANALYSIS SHOWED THAT NO SOFTWARE ERRORS WERE IDENTIFIED DURING THE ANALYSIS. DURING THE ANALYSIS IT WAS IDENTIFIED THAT THE HANDHELD COULD NOT COMPLETE A HARD RESET. THE CAUSE FOR THE ANOMALY IS ASSOCIATED WITH A LOOSE CONNECTOR ON THE MAIN BOARD THAT CAUSED THE CONTACTS BUTTON TO BE NONFUNCTIONAL. SINCE THE BUTTON WAS NOT FUNCTIONING, A HARD RESET COULD NOT BE COMPLETED. ONCE THE CONNECTOR WAS RESEATED, THE BUTTONS FUNCTIONED AS EXPECTED AND A HARD RESET WAS PERFORMED WITH NO ANOMALIES. AN ANALYSIS WAS PERFORMED ON THE RETURNED FLASHCARD, AND 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
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 1073772

    Patients

    Seq Age Sex Outcome Treatment
    1