BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2962100 · Received February 14, 2013

    Report

    Report Number
    1644487-2013-00404
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE HANDHELD HAD A CRACKED SCREEN. NO INFORMATION WAS PROVIDED ON HOW THE CRACKED SCREEN OCCURRED, AS THE PHYSICIAN STATED IT WAS UNKNOWN. THE COMPANY REPRESENTATIVE TRIED TO USE THE HANDHELD TO TROUBLESHOOT; HOWEVER, HE STATED THAT THE HANDHELD DID NOT WORK. A REPLACEMENT HANDHELD WAS REQUESTED AND THE ONE WITH THE CRACKED SCREEN WAS RETURNED FOR PRODUCT ANALYSIS. A VISUAL ANALYSIS OF THE HANDHELD WAS ABLE TO VERIFY THAT THE DISPLAY WAS CRACKED. THE CAUSE FOR THE CRACKED SCREEN IS ASSOCIATED WITH MISHANDLING OF THE DEVICE. ONCE THE SCREEN WAS REPLACED WITH A KNOWN GOOD SCREEN, NO FURTHER ANOMALIES ASSOCIATED WITH THE HANDHELD WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. NO OTHER INFORMATION WAS PROVIDED. THE FLASHCARD WAS ALSO RETURNED FOR PRODUCT ANALYSIS. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. NO OTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65175 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 1075663

    Patients

    Seq Age Sex Outcome Treatment
    1