BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1970055 · Received January 14, 2011

    Report

    Report Number
    1644487-2011-00059
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S DELL X50 WOULD NOT POWER ON. THE HANDHELD WAS PLUGGED INTO THE POWER OUTLET CHARGING, AND THE POWER OUTLET WAS CHANGED, HOWEVER, THE DEVICE WOULD STILL NOT TURN ON. THE LOCK BUTTON WAS IN THE CORRECT POSITION, AND A HARD RESET WAS ALSO PERFORMED, WHICH DID NOT RESOLVE THE PROBLEM. THE HANDHELD HAS BEEN RETURNED TO MANUFACTURER ALONG WITH THE POWER CORD AND SERIAL ADAPTER CABLE WHERE ANALYSIS IS CURRENTLY UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 678292

    Patients

    Seq Age Sex Outcome Treatment
    1