BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 4867317 · Received June 25, 2015

    Report

    Report Number
    1644487-2015-05006
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 2, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE HANDHELD COMPUTER PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL¿S HANDHELD COMPUTER SWITCHED OFF WHILE IT WAS IN USE. A HARD REST WAS RUN BUT THE REPORTED ISSUE PERSISTED. FURTHER INFORMATION WAS RECEIVED STATING THAT HE HANDHELD¿S BATTERY WAS FULLY CHARGED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT HANDHELD COMPUTER PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. RETURN OF THE SUSPECT HANDHELD COMPUTER IS EXPECTED BUT IT HAS NOT OCCURRED TO DATE.

    Description of Event or Problem · 1

    THE HANDHELD COMPUTER WAS RECEIVED BY THE MANUFACTURER FOR ANALYSIS. AN ANALYSIS WAS PERFORMED ON THE RETURNED HANDHELD, WHICH IDENTIFIED THAT THE HANDHELD WAS UNABLE TO CHARGE THE MAIN BATTERY. THE CAUSE FOR THE ANOMALY IS ASSOCIATED WITH BROKEN SOLDER CONNECTIONS ON THE HANDHELD MAIN BOARD. NO OTHER ANOMALIES WERE IDENTIFIED. AN ANALYSIS WAS PERFORMED ON THE RETURNED FLASHCARD. NO ANOMALIES ASSOCIATED WITH THE FLASHCARD SOFTWARE OR THE DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS, BUT IT WAS IDENTIFIED THAT THE FLASHCARD CONTAINED A MAC OSX OPERATING SYSTEM FILE AND FOLDERS. THE PRESENCE OF THE FILE AND FOLDERS IS AN INDICATION THAT THE FLASHCARD WAS INSERTED INTO A DEVICE USING THE MAS OSX OPERATING SYSTEM. THE FILE AND FOLDERS HAD NO IMPACT ON THE VNS SOFTWARE PERFORMANCE. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413529 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1063525

    Patients

    Seq Age Sex Outcome Treatment
    1