BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 5656691 · Received May 16, 2016

    Report

    Report Number
    1644487-2016-01025
    Event Type
    Malfunction
    Date Received
    May 16, 2016
    Date of Event
    April 22, 2016
    Report Date
    April 22, 2016
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE HANDHELD DEVICE (HHD) WAS RECEIVED WITH AN AC ADAPTER, SERIAL CABLE, V8.1 FLASHCARD, AND WITH THE MAIN BATTERY DEPLETED. ANALYSIS CONFIRMED THAT THE BATTERY WOULD NOT ACCEPT A CHARGE RENDERING THE HHD INOPERABLE. ONCE THE BATTERY WAS REPLACED WITH A KNOWN GOOD BATTERY NO ANOMALIES WERE NOTED WITH THE OPERATION OF THE HHD. THE ROOT CAUSE OF THE BATTERY FAILURE IS LIKELY WEAR AND/OR USAGE OF THE BATTERY. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    A USER REPORTED DIFFICULTY OPERATING HIS HANDHELD DEVICE (HHD). ON SITE TROUBLESHOOTING BY A MANUFACTURER FIELD REPRESENTATIVE DETERMINED THAT THE BATTERY OF THE HHD HAD DEPLETED AND THE HHD WOULD NOT POWER ON. AFTER REMOVING AND RESEATING THE BATTERY AND SOFTWARE DATA CARD, AND ENSURING THE BATTERY DOOR WAS PROPERLY LOCKED, THE HHD POWERED ON. HOWEVER, DURING CHARGING THE POWER LIGHT FOR THE HHD WAS FLASHING GREEN AND ORANGE WHILE PLUGGED IN. AFTER UNPLUGGING THE HANDHELD FROM THE WALL TO TEST IF THE HHD COULD BE RUN ON BATTERY POWER THE HHD TURNED OFF. IT WAS SUSPECTED THAT THE UNIT HAD A FAULTY BATTERY AND THE HHD UNIT WAS RETURNED TO THE MANUFACTURER AND IS CURRENTLY UNDERGOING PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313059 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1067570

    Patients

    Seq Age Sex Outcome Treatment
    1