BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3103195 · Received May 9, 2013

    Report

    Report Number
    1723170-2013-00328
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION.A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. SHE WAS ABLE TO REPRODUCE THE REPORTED EVENT. SHE REMOVED PATIENT EXAMES, ARCHIVED AND REMOVED THE CORE FILES, AND THEN RESTARTED THE SYSTEM. SHE ALSO INSERVICED A RESIDENT ON HOW TO DELETE PATIENT EXAMS. AS THE COMPUTER WAS AN OLDER MODEL IT WAS DECIDED TO UPGRADE THE COMPUTER. ON (B)(6) 2013, THE COMPUTER WAS UPGRADED AND THE SYSTEM CHECKOUT SHOWED THAT THE DEVICE WAS FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A HARD DRIVE SPACE ERROR AFTER LOADING A LARGER EXAM WITH MULTIPLE STUDIES. SITE REMOVED A FEW PATIENT EXAMS FROM THE SYSTEM AND THEN THEY WERE ABLE TO IMPORT THE EXAM. THE SYSTEM WAS GIVING A HARD-DRIVE FULL ERROR MESSAGE. THE SYSTEM WAS RUNNING AN OLDER MODEL COMPUTER. SHE SAID THAT THERE WERE ONLY 6 PATIENT EXAMS ON THE SYSTEM. WHEN MOVING FROM THE PATIENT LIST TASK TO THE SET UP EQUIPMENT TASK THE COMPUTER BRIEFLY FLASHED A BLUE SCREEN BEFORE CONTINUING TO THE SET UP EQUIPMENT TASK. NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204286 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1