BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2050135 · Received April 1, 2011

    Report

    Report Number
    1723170-2011-00575
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    August 22, 2010
    Report Date
    August 23, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT PRESENT. THE COMPUTER WAS REPLACED AND RETURNED TO THE MANUFACTURER FOR EVAL. OPERATING SYSTEM CORRUPTION CAUSED THE EVENT. REPLACING THE COMPUTER RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    SITE REPORTED THAT THE SYSTEM WAS NOT WORKING. THEY STATED THAT THE SOFTWARE OPENS TO THE LOGIN SCREEN BUT WHEN THE ICON IS SELECTED, IT GOES TO A BLUE SCREEN THEN CYCLES BACK TO THE LOGIN SCREEN. THEY WERE UNABLE TO GET INTO ROOT, AND A SLAVE MONITOR SHOWED THE SAME BEHAVIOR. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PT WAS 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