BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ARTIS ZEE BIPLANE

    MDR report key: 2445496 · Received February 6, 2012

    Report

    Report Number
    2240869-2012-00010
    Event Type
    Malfunction
    Date Received
    February 6, 2012
    Date of Event
    January 15, 2012
    Report Date
    January 15, 2012
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IZI
    PMA / PMN Number
    K073290
    Removal / Correction Number
    2240869-01/16/12-0001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS IS RELEASING A CUSTOMER SAFETY INFO LETTER TO INFORM CUSTOMERS OF A POTENTIAL MISALIGNMENT IN THE CONNECTION OF THE REMOTE FOOT SWITCH AND THE STATIONARY UNIT. IT WAS DISCOVERED THAT UNDER CERTAIN CIRCUMSTANCES THE WIRELESS FOOT SWITCH WILL LOOSE ITS CONNECTION TO THE AXIOM ARTIS OR ARTIS ZEE AND THE X-RAY RELEASE WITH THE WIRELESS FOOT SWITCH MAY NOT OCCUR. ANY X-RAY RELEASE FROM A WIRED FOOT SWITCH OR HAND SWITCH IS NOT AFFECTED. THE REPORTED POTENTIAL MALFUNCTION MAY OCCUR IF EITHER THE WIRELESS FOOT SWITCH OR THE STATIONARY UNIT IS EQUIPPED WITH IMPROPER FIRMWARE INSTALLED IN THE BLUETOOTH INTERFACE PERFORMING THE COMMUNICATION BETWEEN FOOT SWITCH AND SYSTEM. THE REPORTED MALFUNCTION IS NOT A GENERAL MALFUNCTION, AS A VENDOR UNSYSTEMATICALLY PROVIDED THE IMPROPER FIRMWARE. THERE ARE NO RISKS ASSOCIATED TO PTS PREVIOUSLY PROCESSED OR TREATED WITH THESE SYSTEMS. THE POTENTIAL PROBLEM WILL BE ELIMINATED BY EXCHANGE OF ALL COMPONENTS ON THE SYSTEMS ON WHICH THE IMPROPER FIRMWARE MAY BE INSTALLED. THE APPROPRIATE CORRECTIVE ACTION IS PROVIDED TO THE FIELD AS UI AX044/11/S "REPLACEMENT OF WIRELESS FOOT SWITCH MODULES". IN RESPONSE, SIEMENS HAVE ISSUED A CUSTOMER SAFETY INFO TO AFFECTED CUSTOMERS AS WELL AS A FIX FOR THIS POTENTIAL ISSUE VIA UPDATE INSTRUCTIONS AX046/11/S AND AX044/11/S. THE UPDATE INSTRUCTIONS WERE REPORTED TO THE FDA UNDER 2240869-01/16/12-0001-C.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT THE WIRELESS FOOT SWITCH MALFUNCTIONED DURING AN EXAM. THERE WERE NO INJURIES REPORTED. FACTORY EXPERTS INVESTIGATED THE ISSUE, AND FOUND THAT THE WIRELESS FOOTSWITCH MALFUNCTIONED AND LOST COMMUNICATION WITH THE MAIN SYSTEM UNIT. AS A RESULT, X-RAY RELEASE IS NO LONGER POSSIBLE ALTHOUGH THE SYSTEM STILL INDICATES ITS READINESS. THIS CONDITION MAY CAUSE A DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOM ARTIS ZEE BIPLANE SYSTEM, X-RAY, ANGIOGRAPHIC IZI SIEMENS MEDICAL SOLUTIONS USA, INC. 10094141 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other