BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TRIA NAVIGATION SYSTEM

    MDR report key: 3002367 · Received March 13, 2013

    Report

    Report Number
    1723170-2013-00173
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K001153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION. NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    SUSPECT COMPUTER EVALUATION FINDS: TAMPER SEALS BROKEN. POWERED UP SYSTEM, BOOTED NORMALLY, BUT WITH AUDIBLE FAN NOISE. INTERNAL INSPECTION REVEALED THAT THE VIDEO GRAPHICS CARD (VGC) COOLING FAN IS NOT AT FULL OPERATION. VGC COULD OVERHEAT AND CAUSE REPORTED ISSUE. GRAPHICS CARD MALFUNCTION DIRECTLY CAUSED EVENT. REPLACEMENT COMPUTER SENT TO SITE AND INSTALLED IN SYSTEM FOR ISSUE RESOLUTION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A STEALTHSTATION TRIA NAVIGATION SYSTEM COMPUTER THAT BECAME UNRESPONSIVE. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105442 STEALTHSTATION TRIA NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. TRIA

    Patients

    Seq Age Sex Outcome Treatment
    1