BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANDMARX EVOLUTION

    MDR report key: 2240818 · Received August 16, 2011

    Report

    Report Number
    1723170-2011-01289
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 22, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC TECHNICAL SUPPORT PERSONNEL SLAVED OUT THE VIDEO FROM THE COMPUTER USING THE DVI TO VGA CABLE AND WAS STILL UNABLE TO GET A DISPLAY ON THE MONITOR. THE MEDTRONIC REP ON-SITE REPORTED AIR COMING FROM THE FAN OF THE COMPUTER AND THAT THE MONITOR WAS ALSO POWERED ON. AN RMA WAS ISSUED AND THE COMPUTER WAS SENT BACK FOR EVAL. A REPLACEMENT PART WAS SHIPPED 07/22/2011.

    Description of Event or Problem · 1

    A MEDTRONIC ENT REP REPORTED THE LANDMARX SYSTEM FROZE DURING A TEST FOR SURGERY PREPARATION AND THE MEDTRONIC REP DID A HARD SHUTDOWN. WHEN THE SYSTEM WAS RE-BOOTED, THERE WAS NOTHING DISPLAYED ON THE MONITOR, BUT THE MONITOR DID FLASH FOR A SHORT MOMENT AND THE COMPUTER FAN WAS HEARD RUNNING. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PT WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANDMARX EVOLUTION STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. EVOLUTION NA

    Patients

    Seq Age Sex Outcome Treatment
    1