BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM

    MDR report key: 2081178 · Received April 21, 2011

    Report

    Report Number
    1723170-2011-00853
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    August 3, 2010
    Report Date
    August 3, 2010
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER RMA, A COMPUTER AND POWER CABLE RETRACTOR WERE SENT TO SITE. UPON EVAL OF COMPUTER, IT WAS VERIFIED THAT THE CMOS BATTERY HAS LOW VOLTAGE, AND BULGING CAPS ON THE MOTHER BOARD. PENDING MB REPLACEMENT. UPON RETURN OF POWER RETRACTOR, A CONTINUITY CHECK REVEALED AN OPEN IN THE BROWN WIRE. THE CABLE IS CUT AS IT EXITS THE CABLE RETRACTOR CORE. NO IMPACT ON PT OUTCOME REPORTED.

    Description of Event or Problem · 1

    SITE REPORTED THAT THE TREON SYSTEM MADE A POPPING NOISE AND STARTED SMOKING WHEN IT WAS TURNED ON. THEY TURNED IT OFF AND REMOVED IT FROM THE OPERATING ROOM. THEY SAID IT IS MAKING A FAINT CHIRPING NOISE NOW. 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