BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2475764 · Received February 15, 2012

    Report

    Report Number
    1644487-2012-00382
    Event Type
    Malfunction
    Date Received
    February 15, 2012
    Date of Event
    January 26, 2012
    Report Date
    January 26, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    A COMPANY REP REPORTED THAT HIS HANDHELD COMPUTER COULD NOT TURN ON. THE BATTERY WAS ACCIDENTLY DEPLETED COMPLETELY, AND THEN THE COMPUTER WAS PLUGGED BACK INTO THE POWER SOURCE. THE POWER LIGHT WAS REPORTEDLY COMING ON PERIODICALLY BUT NOT CONSISTENTLY. WHEN HE PUSHED THE POWER ON, NOTHING HAPPENED. A HARD RESET WAS PERFORMED WITH NO RESULTS, AND IT WAS CONFIRMED THAT THE LOCK BUTTON WAS NOT ACCIDENTLY SWITCHED ON AND ALL OF THE WIRES CABLES WERE IN PLACE. THE BATTERY WAS REMOVED, WHICH HAD NO PHYSICAL ABNORMALITIES AND REPLACED IT, PLUGGED IT BACK IN, AND ATTEMPTED ANOTHER HARD RESET WITHOUT RESULTS. THE REP DID NOT HAVE ANOTHER COMPUTER TO TROUBLESHOOT. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS, BUT ANALYSIS HAS NOT BEEN COMPLETED TO DATE. NO PTS WERE AFFECTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE MUZ CYBERONICS, INC. 250 857134

    Patients

    Seq Age Sex Outcome Treatment
    1