BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ARTIS ZEEGO

    MDR report key: 5952115 · Received September 15, 2016

    Report

    Report Number
    2240869-2016-04999
    Event Type
    Malfunction
    Date Received
    September 15, 2016
    Date of Event
    August 25, 2016
    Report Date
    August 25, 2016
    Manufacturer
    SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY
    Product Code
    IZI
    PMA / PMN Number
    K141574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENTS. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. WHEN OPERATING AN X-RAY TUBE, HEAT IS GENERATED DEPENDENT ON THE DEGREE OF USE. TO REMOVE THE HEAT, THE X-RAY TUBE IS EQUIPPED WITH AN INTERNAL PRIMARY COOLING. GENERATED HEAT IS REMOVED VIA AN OIL CIRCUIT AND HEAT IS REMOVED WITH A SECONDARY WATER CIRCUIT. IN THE EVENT OF A COOLING SYSTEM FAILURE, THE SYSTEM CAN CONTINUE TO BE OPERATED FOR A PERIOD OF TIME. THE FAILURE IS ANNOUNCED TO THE OPERATOR BY DISPLAYING "TUBE HOT, HAVE A BREAK" AND THE OPERATOR CAN THAN DECIDE TO CONTINUE OR TERMINATE THE PROCEDURE. THIS KIND OF FAILURE IS VERY RARE, HOWEVER, A FIELD CORRECTIVE ACTION WAS REPORTED TO THE FDA VIA 2240869-07/15/16-0022-C. PARTS OF THE SYSTEM COOLING HAVE BEEN CHANGED AND NO RECURRENCE HAS BEEN COMMUNICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEEGO SYSTEM. THE CUSTOMER REPORTED AN ERROR MESSAGE "TUBE TOO HOT" WHILE SYSTEM WAS IN BYPASS AND NO XRAY WAS POSSIBLE. A MOBILE C-ARM WAS USED TO COMPLETE THE PROCEDURE. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604048 AXIOM ARTIS ZEEGO INTERVENTIONAL, FLUOROSCOPIC, XRAY SYSTEM IZI SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY 10280959

    Patients

    Seq Age Sex Outcome Treatment
    1