BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2081201 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00835
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PER RMA, A REPLACEMENT COMPUTER WAS SENT TO SITE AND RESOLVED ISSUE. UPON EVAL OF RETURNED COMPUTER, IT PASSED ALL TESTING. NO CORE FILES FOUND. ONE EXAM WAS 588 MB. NO HARDWARE PROBLEM FOUND AS ALL TESTING PASSED. DID NOT CAUSE EVENT.

    Description of Event or Problem · 1

    MEDTRONIC ENT REP REPORTED THAT THE SCREEN ON THE NAVIGATION SYSTEM WENT BLACK AND EXITED TO THE LOGIN SCREEN. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PT WAS PRESENT.

    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