BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3841348 · Received May 30, 2014

    Report

    Report Number
    1723170-2014-00630
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 2, 2014
    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. MEDTRONIC INVESTIGATION OF RETURNED DEVICE FOUND THAT THE FAULT LIGHT WAS ILLUMINATED AT POWER UP. A CHECK OF THE EVENT LOG INDICATED THE BUMP SENSOR HAD BEEN ACTIVATED. THE PSU FAILED AN AAK TEST AT .51 MM WITH LINE SEPARATION DETECTED. THE REPORTED EVENT WAS CONFIRMED. THE ROOT CAUSE WAS AN ELECTRICAL ISSUE WITH A SYSTEM FAULT CODE OF BUMP SENSOR ACTIVATED ON THE CAMERA. THE DEVICE WAS SENT TO THE VENDOR FOR ADDITIONAL ANALYSIS. THE VENDOR VERIFIED THAT THE DEVICE BUMP LOG NEEDED TO BE RESET FOLLOWED BY RE-CHARACTERIZATION WITH THE FIRMWARE AS IT WAS RECEIVED. THE DEVICE WAS REPLACED AND THE SYSTEM WAS REPORTED TO BE FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A NAVIGATION SYSTEM CAMERA HAD A FAULT LIGHT AND WAS NOT DETECTING INSTRUMENTS. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318817 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1