BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIOM ARTIS FA

    MDR report key: 896762 · Received August 13, 2007

    Report

    Report Number
    2240869-2007-00015
    Event Type
    Death
    Date Received
    August 13, 2007
    Date of Event
    July 16, 2007
    Report Date
    July 19, 2007
    Manufacturer
    SIEMENS AG MED
    Product Code
    IZI
    PMA / PMN Number
    K021021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MOTOR CONTROLLER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTEDLY EXPERIENCED AN ERROR ON THE SYSTEM. THE SITE'S IN-HOUSE SERVICE PERSONNEL WERE CALLED AND CHECKED THE UNIT, BUT THEY COULD NOT DETERMINE THE CAUSE OF THE PROBLEM. ON THE FOLLOWING DAY, A PATIENT WENT INTO CARDIAC ARREST WHILE UNDERGOING AN ENDOVASCULAR SURGERY PROCEDURE. IN ORDER TO ADMINISTER CPR, THE OPERATOR ATTEMPTED TO MOVE THE SYSTEM (TABLETOP AND STAND) OUT OF THE OPERATING POSITION. THE UNIT DISPLAYED AN ERROR, AND THE STAND AND TABLE WOULD NOT RESPOND TO THE OPERATOR'S COMMAND TO MOVE. AS A RESULT, THE OPERATOR MANUALLY MOVED THE UNIT IN ORDER TO PERFORM CPR. CPR WAS PERFORMED ON THE PATIENT AT THE TIME OF THE EVENT; HOWEVER, THE PATIENT EXPIRED ON THE TABLE. AFTER THE INCIDENT, THE SYSTEM WAS LATER REBOOTED. THIS CLEARED THE ERROR AND THE UNIT FUNCTIONED PROPERLY. LATER INVESTIGATION OF THE ERROR LOGS INDICATED THAT THE PROBLEM WAS CAUSED BY A DEFECTIVE MOTOR CONTROLLER FOR THE TABLE. THE MOTOR CONTROLLER WAS REPLACED BY THE SITE'S IN-HOUSE SERVICE PERSONNEL, AND WE ARE UNAWARE OF ANY FURTHER ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOM ARTIS FA SYSTEM, X-RAY, ANGIOGRAPHIC IZI SIEMENS AG MED 05904441 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death