BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1820087 · Received August 24, 2010

    Report

    Report Number
    1644487-2010-01930
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 2, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGEON'S HANDHELD COMPUTER WAS NOT HOLDING CHARGE AS IT SHOULD. THE SURGEON INDICATED THE HANDHELD WOULD WORK FINE WHEN CONNECTED TO THE AC POWER SUPPLY, BUT WOULD TURN OFF AS SOON AS IT WAS DISCONNECTED FROM THE AC POWER SUPPLY. A NEW HANDHELD WAS PROVIDED TO THE SURGEON AND THE REPORTED HANDHELD WAS RETURNED TO THE MANUFACTURER TO UNDERGO PRODUCT ANALYSIS. PRODUCT ANALYSIS WAS COMPLETED ON THE RETURNED HANDHELD COMPUTER. PRODUCT ANALYSIS OF THE HANDHELD REVEALED NO ANOMALIES ASSOCIATED WITH THE MAIN BATTERY WERE IDENTIFIED DURING THE ANALYSIS. THE CAUSE FOR THE REPORTED COMPLAINT IS ASSOCIATED WITH BROKEN SOLDER CONNECTIONS ON THE HANDHELD MAIN BOARD. AFTER THE BROKEN CONNECTIONS WERE RE-SOLDERED TO THE MAIN BOARD, NO FURTHER ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. MOREOVER, PRODUCT ANALYSIS ON THE RETURNED FLASHCARD REVEALED 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 584956

    Patients

    Seq Age Sex Outcome Treatment
    1