BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 4143500 · Received October 6, 2014

    Report

    Report Number
    1644487-2014-02556
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS OF THE HANDHELD CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION. 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 PHYSICIAN'S HANDHELD WOULD FREEZE AT THE BLUE WINDOWS SCREEN AFTER RESET. TROUBLESHOOTING WAS PERFORMED, WHICH RESOLVED THE ISSUE. IT WAS LATER REPORTED THAT THE HANDHELD STOPPED WORKING AGAIN AND TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE. IT WAS REPORTED THAT THE SCREEN LOCK WAS NOT ENGAGED AND THE SCREEN WAS CLEAN. IT WAS REPORTED THAT THE ALIGN SCREEN WOULD NOT WORK AND WHEN TAPPING ON THE SCREEN WITH THE STYLUS THERE WAS NO RESPONSE. A NEW PROGRAMMING TABLET WAS SENT TO THE PHYSICIAN AND THE HANDHELD AND WAND WERE RECEIVED FOR ANALYSIS. ANALYSIS OF THE WAND WAS COMPLETED ON (B)(4) 2014. THE PROGRAMMING WAND PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS OF THE HANDHELD WAS COMPLETED ON (B)(4) 2014. DURING THE ANALYSIS, IT WAS IDENTIFIED THAT THE HANDHELD WAS UNABLE TO ADVANCE PAST THE WELCOME SCREEN. 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. ANALYSIS OF THE FLASHCARD WAS COMPLETED ON (B)(4) 2014. 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
    622332 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS INC MODEL 250 1075854

    Patients

    Seq Age Sex Outcome Treatment
    1