BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3233793 · Received July 18, 2013

    Report

    Report Number
    1644487-2013-02169
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO ANY SERIOUS INJURY OR DEATH.

    Description of Event or Problem · 1

    ANALYSIS OF THE COMPUTER AND FLASHCARD WAS COMPLETED. 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. THERE WERE NO PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITIONS FOUND WITH THE HANDHELD COMPUTER. THE FLASHCARD SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS.

    Description of Event or Problem · 1

    ON (B)(6) 2013 INFORMATION WAS RECEIVED FROM THE REPORTER THAT THE PHYSICIAN¿S HANDHELD COMPUTER CANNOT ALIGN ITS SCREEN. SEVERAL HARD RESETS WERE PERFORMED ON THE COMPUTER, WITH NO CHANGES RESULTING. THE SCREEN WAS WIPED VERY CLEANLY WITH A DRY TOWEL/CLOTH, BUT THE SCREEN WAS STILL UNABLE TO ALIGN. THE HANDHELD COMPUTER AND ITS FLASHCARD HAVE BEEN RECEIVED FOR PRODUCT ANALYSIS. ADDITIONAL INFORMATION IS PENDING COMPLETION OF MANUFACTURER PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335472 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 1075839

    Patients

    Seq Age Sex Outcome Treatment
    1