BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2982962 · Received February 28, 2013

    Report

    Report Number
    1644487-2013-00551
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 5, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    OUR COUNTRY REPRESENTATIVE IN CANADA REPORTED THAT ONE OF HER PHYSICIAN'S IS HAVING A PROBLEM WITH HIS HANDHELD CONTINUING TO GO AROUND AND AROUND AT THE ALIGN SCREEN. THE PROBLEM STARTED YESTERDAY (B)(6) 2013 AND THE PHYSICIAN WAS NOT ABLE TO GET IT OFF THE ALIGN SCREEN. A RESET WAS PERFORMED SEVERAL TIMES AND WHEN IT GETS TO THE ALIGN SCREEN IT JUST KEEPS GOING AROUND AND AROUND. A CARD WAS USED TO CLEAN AROUND THE CORNERS OF THE SCREEN AND IT HAS NOT HELPED. THE HANDHELD COMPUTER IS BEING RETURNED FOR ANALYSIS. AT THIS TIME IT HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    THE HANDHELD COMPUTER WAS RECEIVED WITH AN AC ADAPTER, SERIAL CABLE, V8.1 FLASHCARD, AND WITH THE MAIN BATTERY DEPLETED. THE HANDHELD DEVICE WAS POWERED USING THE RETURNED POWER SUPPLY WITH NO ANOMALIES. THE ANALYSIS DEPARTMENT ATTEMPTED TO PERFORM THE INITIAL SETUP PROCESS, BUT WAS UNABLE. SEVERAL ATTEMPTS TO COMPLETE THE ALIGN SCREEN PROCESS WERE UNSUCCESSFUL. THE CROSSHAIR ON THE DISPLAY WOULD MOVE WHEN TOUCHED, BUT THE UTILITY WOULD NOT ADVANCE TO THE NEXT SCREEN. THE TOP COVER WAS REMOVED AND THE DISPLAY CLEANED. 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 DEBRIS THAT WAS ON THE DISPLAY. ONCE THE DISPLAY WAS CLEANED, NO FURTHER ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE IDENTIFIED DURING THE ANALYSIS. AN ANALYSIS WAS PERFORMED ON THE RETURNED FLASHCARD. 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
    88181 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 1063530

    Patients

    Seq Age Sex Outcome Treatment
    1