BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2900425 · Received January 7, 2013

    Report

    Report Number
    1644487-2013-00082
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    November 15, 2012
    Report Date
    December 20, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING MANUFACTURER ANALYSIS OF A VNS DELL X50 COMPUTER FOR REPORTED COSMETIC DEAD PIXELS, NO DISPLAY ANOMALIES WERE IDENTIFIED, BUT IT WAS NOTED THAT THE RETURNED ITE AC ADAPTER WAS UNABLE TO INITIALLY POWER THE RETURNED HANDHELD COMPUTER WITH A DEPLETED BATTERY. THE LIKELY CAUSE FOR THE ANOMALY IS ASSOCIATED WITH THE POWER SUPPLY BEING UNABLE TO INITIALLY MEET THE POWER DEMANDS OF THE HANDHELD COMPUTER AS IT ATTEMPTS TO CHARGE THE BATTERY AND POWER ON. ALTHOUGH THE AC ADAPTER COULD NOT POWER THE HANDHELD, IT DID PROVIDE 12MA OF CURRENT ALLOWING IT TO CHARGE THE BATTERY SLOWLY. ONCE THE BATTERY WAS PARTIALLY CHARGED, THE HANDHELD WAS ABLE TO POWER ON USING THE AC ADAPTER. NO OTHER ANOMALIES WERE IDENTIFIED. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE COMPUTER WAS NEVER RELEASED FOR INITIAL USE BY THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7584 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS INC MODEL 250 1067570

    Patients

    Seq Age Sex Outcome Treatment
    1