BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3260419 · Received August 1, 2013

    Report

    Report Number
    1644487-2013-02289
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Date of Event
    July 12, 2013
    Report Date
    July 12, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED ALL FUNCTIONAL TEST WERE PASSED BY THE HANDHELD COMPUTER PRIOR TO DISTRIBUTION. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    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

    ON (B)(6) 2013 INFORMATION WAS RECEIVED FROM THE REPORTER THAT THE PHYSICIAN¿S HANDHELD COMPUTER WAS NOT RESPONDING TO ANY TAPS OR TOUCHES ON THE SCREEN. A HARD RESET WAS PERFORMED, BUT WHEN THE HANDHELD COMPUTER REACHED THE SCREEN ALIGNMENT SCREEN, THE PHYSICIAN ATTEMPTED TO ALIGN THE SCREEN BUT IT WOULD NOT RESPOND. THE SCREEN WAS WIPED DOWN WITH A DRY CLOTH IN AN ATTEMPT TO CLEAN THE SCREEN AND THE CREVICE AROUND THE SCREEN. AFTER BEING CLEANED ANOTHER HARD RESET WAS PERFORMED ON THE HANDHELD COMPUTER AND THE SCREEN WOULD STILL NOT RESPOND. A REVIEW OF THE MANUFACTURER¿S DEVICE RECORDS WAS PERFORMED AND CONFIRMED THAT THE HANDHELD COMPUTER PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. THE PHYSICIAN¿S PROGRAMMING WAND, HANDHELD COMPUTER, AND SOFTWARE FLASHCARD WERE RETURNED TO THE MANUFACTURER AND ARE PENDING ANALYSIS.

    Description of Event or Problem · 1

    AN ANALYSIS WAS PERFORMED ON THE RETURNED HANDHELD. DURING THE ANALYSIS IT WAS VERIFIED THAT THE TOUCHSCREEN DISPLAY WAS UNRESPONSIVE. 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. AN ANALYSIS WAS PERFORMED ON THE RETURNED FLASHCARD AND NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360637 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 878078

    Patients

    Seq Age Sex Outcome Treatment
    1