BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2072377 · Received April 8, 2011

    Report

    Report Number
    1723170-2011-00770
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. THE RETURNED PRODUCT DID NOT MEET SPECIFICATIONS. NO ISSUES OBSERVED AT POWER UP. AFTER RUNNING FOR 5 MINUTES, THE IMAGE ON THE LCD WENT WHITE, WITH 2 BLACK VERTICAL LINES. THE DEVICE MALFUNCTION WAS CONFIRMED AND DIRECTLY RELATED TO THE REPORTED EVENT. A REPLACEMENT PART WAS SENT TO THE SITE AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE MONITOR ON THE STEALTHSTATION TREON WAS NOT DISPLAYING PROPERLY. THERE WAS A BLUE SCREEN WITH VERTICAL LINES. THE MEDTRONIC REPRESENTATIVE PERFORMED TROUBLESHOOTING AND WAS ABLE TO SEE THE DISPLAY IMAGE FROM THE TREON USING A DIFFERENT MONITOR. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. TREON NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE