BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2872909 · Received December 13, 2012

    Report

    Report Number
    1723170-2012-00709
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    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

    COMPUTER HARD DRIVE FAILED TESTING. REPLACED HARD DRIVE AND COMPUTER THEN PASSED ALL TESTING.

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION. RMA ISSUED. REPLACEMENT COMPUTER SHIPPED TO SITE (B)(4) 2012. SUSPECT COMPUTER HAS BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. EVALUATION RESULTS NOT YET AVAILABLE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED REPEATED EXITS AND SOFTWARE FAILURES ON A NEW INSTALL OF A STEALTHSTATION S7 SYSTEM. THIS EVENT WAS REPORTED OUTSIDE THE OPERATING ROOM, THEREFORE, NO PATIENT WAS PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1