BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3227612 · Received July 15, 2013

    Report

    Report Number
    1644487-2013-02122
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT A PHYSICIAN¿S HANDHELD DEVICE (HHD) WAS FROZEN AT AN UNKNOWN SCREEN. TROUBLESHOOTING WAS PERFORMED: THE HHD WAS UNPLUGGED FROM THE WALL, THE DEVICE BATTERY WAS INTENTIONALLY DEPLETED, THE HHD WAS RESET, AND THE HANDHELD WAS USED WITH OTHER WANDS. THE HHD DID NOT WORK WITH OTHER WANDS. (WHEN A NEW HANDHELD WAS USED WITH THE SAME WANDS, THE ISSUE DID NOT OCCUR.) IT WAS PRESUMED THAT THE DEVICE FROZE ON THE INTERROGATION SCREEN. ADDITIONAL TROUBLESHOOTING WAS PERFORMED: THE DEVICE BATTERY WAS DEPLETED, THE DEVICE WAS RECHARGED AND RESET, AND ALL CONNECTIONS WERE CONFIRMED. THE DEVICE DID NOT FREEZE AFTER THIS WAS PERFORMED. THE EVENT OCCURRED WITH MULTIPLE SCREENS. THE DEVICE IS NOT EXPECTED FOR RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327427 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 1075832

    Patients

    Seq Age Sex Outcome Treatment
    1