BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3222304 · Received July 12, 2013

    Report

    Report Number
    1723170-2013-00510
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    March 5, 2013
    Report Date
    June 26, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. RMA ISSUED. REPLACEMENT CAMERA SHIPPED DIRECTLY TO SITE. MEDTRONIC EVALUATION OF RETURNED SUSPECT CAMERA FINDS THAT AS REPORTED, THE PSU POWERED UP WITH AN INTERMITTENT FAULT LIGHT. A CHECK OF THE EVENT LOG REVEALED A HISTORY OF THE ILLUMINATOR CURRENT MOVING IN AND OUT OF RANGE. PER VENDOR EVALUATION, THE UNIT HAS A FAULTY RIGHT SIDE ILLUMINATOR BOARD WHICH REQUIRES REPLACEMENT. THE MEDTRONIC INVESTIGATOR WAS ABLE TO DUPLICATE THE ISSUE. THE ELECTRICAL SYSTEM FAULT CODE DIRECTLY CAUSED THIS EVENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT IN PREPARING FOR A SURGERY, THE CAMERA JAR LIGHT CAME ON. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321549 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1