BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3021284 · Received March 26, 2013

    Report

    Report Number
    1644487-2013-00807
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    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

    ANALYSIS FOUND THAT THE SERIAL CABLE WAS UNABLE TO ESTABLISH COMMUNICATION. DURING TESTING IT WAS IDENTIFIED THAT THE SERIAL CABLE WAS UNABLE TO ESTABLISH COMMUNICATION USING A KNOWN GOOD WAND AND HANDHELD. THE CAUSE FOR THE COMMUNICATION DIFFICULTIES IS ASSOCIATED WITH THREE BROKEN WIRE CONNECTIONS ON THE AXIM CONNECTOR PLUG. ONCE THE WIRES WERE SOLDERED BACK ONTO THE DELL AXIM CONNECTOR PLUG, THE SERIAL CABLE WAS ABLE TO ESTABLISH COMMUNICATION BETWEEN THE HANDHELD AND WAND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE PRACTITIONER'S HANDHELD WAS EXPERIENCING COMMUNICATION PROBLEMS WITH ONE OF THE PROGRAMMING SYSTEMS IN THE OFFICE. A COMPANY REPRESENTATIVE PERFORMED TROUBLESHOOTING ON THE SYSTEM BY SWAPPING OUT DIFFERENT ASPECTS OF THE SYSTEM AND NARROWED THE PROBLEM DOWN TO THE HANDHELD SERIAL CABLE. THE SERIAL CABLE WAS RETURNED TO DEVICE MANUFACTURER ON (B)(4) 2013 FOR ANALYSIS. ANALYSIS IS UNDERWAY; HOWEVER, HAS NOT YET BEEN COMPLETED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123794 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1075850

    Patients

    Seq Age Sex Outcome Treatment
    1