BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2081203 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00839
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INFO AS NO PT WAS INVOLVED IN THIS CONCERN. PER RMA A REPLACEMENT COMPUTER WAS SENT TO SITE. PER RMA A REPLACEMENT COMPUTER WAS SENT TO SITE. UPON EVAL OF RETURNED COMPUTER, COMPUTER DID NOT FREEZE DURING TESTING. FOUND NO APPLICATION CORE FILES. DID FIND 18GB OF EXAMS ON HDD. COMPUTER PASSED ALL TESTING WITH NO PROBLEM FOUND.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THE FUSION SYSTEM FROZE. 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