BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2770217 · Received October 3, 2012

    Report

    Report Number
    1644487-2012-02499
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 6, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PHYSICIAN'S DELL X50 HANDHELD COMPUTER WAS FROZEN AT THE (B)(4) SCREEN. THE COMPANY REPRESENTATIVE PERFORMED A HARD RESET MULTIPLE. THE TC CHECKED THE SCREEN FOR DEBRIS AND VERIFIED THAT THE LOCK BUTTON WAS NOT ENGAGED. A REPLACEMENT COMPUTER WAS PROVIDED TO THE SITE. AN ANALYSIS WAS PERFORMED ON THE RETURNED HANDHELD AND THE REPORTED ALLEGATION WAS VERIFIED. DURING THE ANALYSIS, IT WAS IDENTIFIED THAT THE HANDHELD WAS UNABLE TO ADVANCE PAST THE SCREEN ALIGNMENT UTILITY. THE CAUSE FOR THE DISPLAY ANOMALY IS ASSOCIATED WITH RESISTANCE VALUES BEING HIGHER THAN EXPECTED IN THE TOUCH SCREEN CIRCUITRY. ONCE THE DISPLAY WAS REPLACED WITH A KNOWN GOOD DISPLAY, NO FURTHER ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE IDENTIFIED DURING THE ANALYSIS. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS INC MODEL 250 874821

    Patients

    Seq Age Sex Outcome Treatment
    1