BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2944993 · Received February 6, 2013

    Report

    Report Number
    1644487-2013-00301
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 9, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICVE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    THE HANDHELD DEVICE AND SOFTWARE FLASHCARD WERE RETURNED ON (B)(4) 2013. PRODUCT ANALYSIS WAS PERFORMED. AN ANALYSIS WAS PERFORMED ON THE RETURNED HANDHELD, AND NO ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS DELL X50 COMPUTER'S SCREEN WOULD NOT ALIGN. PERFORMING HARD AND SOFT RESETS DID NOT RESOLVE THE ISSUE. THE COMPUTER SERIAL NUMBER PROVIDED BY THE REPORTER MAY NOT BE CORRECT. ATTEMPTS FOR ADDITIONAL INFORMATION AND RETURN OF THE COMPUTER ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49826 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1