BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1190854 · Received September 24, 2008

    Report

    Report Number
    1644487-2008-02329
    Event Type
    Malfunction
    Date Received
    September 24, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 25, 2008
    Manufacturer
    CYBERONICS INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS HP JORNADA HANDHELD COMPUTER WOULD NOT TURN ON. IT DID TURN ON ONCE AND THEN IT TURNED OFF BEFORE IT WAS ABLE TO BE USED. THE HANDHELD COMPUTER AND FLASHCARD WERE RETURNED FOR PRODUCT ANALYSIS. ANALYSIS OF THE FLASHCARD REVEALED THAT THE 2577 FOLDER WAS MISSING. A ROOT CAUSE FOR THE MISSING FOLDER COULD NOT BE DETERMINED BASED ON THE RETURNED FLASHCARD AND SOFTWARE, BUT AN ANALYSIS OF THE COMPUTER IDENTIFIED THAT THE SOFTWARE HAD BEEN INSTALLED GIVING THE INDICATION THAT THE FOLDER WAS PRESENT IN THE FLASHCARD AT SOME POINT IN TIME. ANALYSIS OF THE COMPUTER REVEALED NO ANOMALIES AND IT PERFORMED AS INTENDED. THE REMAINING BATTERY POWER WAS AT 25% AFTER AN HOUR OF TESTING, WHICH IS OUT OF SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC. MODEL 250 521382

    Patients

    Seq Age Sex Outcome Treatment
    1