BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1950132 · Received December 7, 2010

    Report

    Report Number
    1644487-2010-02743
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN'S DELL X50 HANDHELD DEVICE WOULD NOT TURN ON. THE HANDHELD WAS PLUGGED IN OVER THE WEEKEND; HOWEVER, THE POWER LIGHT ON THE HANDHELD NEVER TURNED GREEN AND ATTEMPTS TO TURN ON THE HANDHELD WHILE PLUGGED IN WHERE UNSUCCESSFUL. THE PHYSICIAN STATED, HE KEEPS THE HANDHELD IN HIS OFFICE AT ALL TIMES. THE CONNECTIONS ALL APPEARED TO BE SECURE AND THE HANDHELD HAS NOT BEEN DROPPED. A REPLACEMENT HANDHELD WAS SENT TO THE PHYSICIAN AND GOOD FAITH ATTEMPTS TO OBTAIN THE DELL X50 IN QUESTION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE MUZ CYBERONICS, INC. 678296

    Patients

    Seq Age Sex Outcome Treatment
    1