BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUSION NAVIGATION SYSTEM

    MDR report key: 2974877 · Received February 22, 2013

    Report

    Report Number
    1723170-2013-00118
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001284
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT DEVICE RECEIVED FOR EVALUATION. INSPECTED THE CART AND ALL OF THE CASTERS WERE ATTACHED SECURELY TO THE BASE. THE LOCKING TAB ON THE RIGHT FRONT CASTER WAS BROKEN OFF. ALL OF THE CASTERS ARE CRACKED AT THE GLUE JOINT WHERE THE LEFT AND RIGHT HALF ARE ASSEMBLED. NEW SYSTEM CART SENT TO SITE AND RESOLVED ISSUE.

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION. MEDTRONIC INVESTIGATION FINDS FUSION CASTERS ARE NOT ABLE TO BE REPLACED IN THE FIELD DUE TO A CUSTOM WRENCH NEEDED TO TAKE THEM OFF. MEDTRONIC FIELD REPRESENTATIVE CONFIRMS THE NEW SYSTEM HAS BEEN INSTALLED AND IS WORKING PROPERLY. NO FURTHER ISSUES HAVE BEEN REPORTED. SUSPECT CASTER SWIVEL LOCK AND FUSION CART HAVE SHIPPED; HOWEVER, HAVE NOT BEEN RECEIVED BY MANUFACTURER FOR FURTHER EVALUATION

    Description of Event or Problem · 1

    A MEDTRONIC ENT REPRESENTATIVE REPORTED A FUSION NAVIGATION SYSTEM WAS DELIVERED TO THE SITE WITH A CASTER LOCK BROKEN OFF. THE BROKEN CASTER LOCK RESULTED IN DIFFICULTY PUSHING THE SYSTEM CART. SINCE THIS EVENT WAS REPORTED OUTSIDE THE OPERATING ROOM NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78534 FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1