BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3912409 · Received July 3, 2014

    Report

    Report Number
    1644487-2014-01684
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    THE HANDHELD AND SOFTWARE WERE RECEIVED FOR ANALYSIS. ANALYSIS OF THE HANDHELD WAS COMPLETED ON (B)(4) 2014. NO ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS OF THE HANDHELD 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE WAS HAVING ISSUES WITH HER HANDHELD DEVICE. THE NURSE WAS UNABLE TO MOVE PAST THE ALIGNMENT SCREEN ON HER HANDHELD DESPITE PERFORMING HARD RESETS. THE LOCK BUTTON WAS NOT ENGAGED AND THE BATTERY LATCH WAS CLOSED. THE HANDHELD DEVICE HAS NOT BEEN RETURNED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391040 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1073773

    Patients

    Seq Age Sex Outcome Treatment
    1