BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2050118 · Received April 1, 2011

    Report

    Report Number
    1723170-2011-00578
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    September 28, 2010
    Report Date
    September 28, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPUTER WAS REPLACED AND THIS RESOLVED THE ISSUE. THE FAULTY COMPUTER WAS NOT RETURNED FOR ANALYSIS OR TESTING.

    Description of Event or Problem · 1

    SITE REPORTED THAT THE SYSTEM IS SLOW AND FREEZING AT THE POINT WHERE HE SELECTS THE PROFILE. THE SYSTEM JUST SITS AT THIS SCREEN AND DOES NOTHING. THIS WAS AFTER COMPLETING A CASE AND GETTING READY FOR THE NEXT. WHEN THEY CLICK ON ANYTHING THE SYSTEM HANGS AND THEY HAVE TO SHUT DOWN THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSION NAVIGATION SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. FUSION NA

    Patients

    Seq Age Sex Outcome Treatment
    1