BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2211866 · Received August 10, 2011

    Report

    Report Number
    1644487-2011-01822
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 16, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    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 BY A COMPANY REPRESENTATIVE THAT A NURSE'S HANDHELD COMPUTER WAS COMPLETELY LOCKED ON ONE OF THE SCREENS ASSOCIATED WITH A HARD RESET AND WILL NOT MOVE. FURTHER INFORMATION FROM A COMPANY REPRESENTATIVE INDICATED THAT DISCHARGING AND RECHARGING THE HANDHELD LED TO CORRECT FUNCTIONALITY FOR THE DEVICE. HOWEVER, UPON FURTHER TESTING THE HANDHELD BECAME LOCKED AGAIN. THE COMPANY REPRESENTATIVE INDICATED THAT THE INITIAL REPORTER HAD THE HANDHELD UNCHARGED AS SHE WAS ON VACATION. UPON RETURN, THE NURSE RECHARGED THE HANDHELD AND IT NATURALLY WENT THROUGH A HARD RESET. AS THE SOFTWARE INSTALLED THE NURSE TRIED TO SWITCH IT OFF WHEN THE HANDHELD PROMPTED TO CLEAR DATA. THE HANDHELD WAS "STUCK" ON THE CLEAR ALL DATA. DESPITE HARD RESETS AND REMOVAL OF THE FLASHCARD NOTHING WORKED. THE HANDHELD WAS RETURNED TO THE MANUFACTURER AND UNDERWENT ANALYSIS. ANALYSIS OF THE HANDHELD REVEALED THAT A LOOSE/DISCONNECTED CABLE WAS FOUND THAT MADE THE CONTACTS BUTTON UNRESPONSIVE. DURING THE ANALYSIS, IT WAS VERIFIED THAT THE HANDHELD COULD NOT COMPLETE A HARD RESET. ONCE THE CABLE WAS RESEATED TO THE MAIN BOARD, NO FURTHER ANOMALIES WERE IDENTIFIED. MOREOVER, ANALYSIS ON THE SOFTWARE REVEALED THAT THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 842376

    Patients

    Seq Age Sex Outcome Treatment
    1