BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION IOR SYSTEM

    MDR report key: 2040348 · Received February 15, 2011

    Report

    Report Number
    1723170-2011-00651
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 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

    PT INFO NOT PROVIDED AS NO PT WAS INVOLVED IN THIS CONCERN. A DEVICE EVAL IS STILL IN PROGRESS AS OF THE DATE OF THIS REPORT. WHILE NO PT WAS PRESENT, THIS ISSUE IS BEING REPORTED BECAUSE A SOFTWARE EXIT THAT DOES HAPPEN DURING SURGERY COULD CAUSE A DELAY THAT COULD CAUSE PT HARM.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT THEY WERE DOING A PRE-OP SCAN PRIOR TO A CRANIAL PROCEDURE USING MACH CRANIAL IN THE IOR, AND THE SOFTWARE EXITED. THE MONITORS IN THE ROOM POWER DOWN DURING A SCAN, BUT THE RACK SHOULD STAY ON. THE MEDTRONIC REP REPORTED THAT THE LEFT THE SOFTWARE AT THE LOAD PT SCREEN. WHEN THE MONITORS CAME BACK ON, THE SYSTEM SAID THAT IT WAS SHUTTING DOWN. NO IMPACT TO THE PT, CASE PROCEEDED AS PLANNED USING THE STEALTHSTATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1