BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ARTIS ZEE BIPLANE

    MDR report key: 3035906 · Received April 4, 2013

    Report

    Report Number
    2240869-2013-02304
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 8, 2013
    Manufacturer
    SIEMENS AG
    Product Code
    IZI
    PMA / PMN Number
    K073290
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO INFORMATION RECEIVED BY LOCAL SIEMENS SERVICE FROM THE TECHNOLOGIST AT THE SITE: AT THE EXAM START THE X-RAY TECHS NOTICED THE MESSAGE IVS NOT IN SYNC; THE X-RAY TECHS CLOSED THE CASE AND DID AN EMERGENCY REGISTRATION ON THE SAME PATIENT; THE RADIOLOGIST CONTINUED WITH THE EXAM; THE EXAM CONTINUED WITH WHATEVER FLUORO AND ACQUISITION FRAME RATES WERE WORKING; THE CUSTOMER CALLED SIEMENS SERVICE TECHNICAL SUPPORT, AND TECHNICAL SUPPORT PERSONNEL LOGGED INTO THE SYSTEM; AFTER THE EXAM WAS OVER THE CUSTOMER SHUT DOWN AND BOOTED THE SYSTEM BACK UP; AFTER REBOOT THE CUSTOMER WAS ABLE TO MERGE ALL THE IMAGES FROM THE DIFFERENT FOLDERS INTO 1 PATIENT FOLDER. WE DO NOT HAVE CONFIRMATION OF THE PATIENT'S HEALTH CONDITION PRIOR TO THE EXAM, BUT WE HAVE AN UNVERIFIED REPORT THAT THE PATIENT WAS IN CRITICAL CONDITION. THE INVESTIGATION IS ON-GOING. THE ARTIS WAS CORRECTLY FUNCTIONING WHEN THE LOCAL SIEMENS SERVICE ENGINEER ARRIVED AT THE SITE THE FOLLOWING DAY, (B)(4) 2013. THE CUSTOMER IS NOT SHARING ADDITIONAL INFORMATION AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH SIEMENS' COMPLAINT PROCESS THAT ON (B)(6) 2013, AN EQUIPMENT MALFUNCTION OCCURRED. THE CUSTOMER OBSERVED A MESSAGE ON ONE OF THE MONITORS THAT STATED THAT "THE B PLANE IS NOT IN SYNC WITH THE IVS (IMAGING VISUALIZATION SYSTEM) COMPUTER." HOWEVER, THE CUSTOMER WAS ABLE TO "DO A CEREBRAL CASE, EVEN THOUGH THE PATIENT REGISTRATION WAS REJECTED BY THE IVS COMPUTER." WE ARE NOT CURRENTLY AWARE OF THE PATIENT'S CONDITION. THERE HAS BEEN AN UNVERIFIED REPORT THAT THE PATIENT EXPIRED, BUT WE DON'T KNOW WHEN, WHERE, OR IF THIS OCCURRED. PRESENTLY, WE ARE UNABLE TO RETRIEVE ANY ADDITIONAL PATIENT INFORMATION FROM THE CUSTOMER. IN A CUSTOMER MEDWATCH REPORT ((B)(4)) RECEIVED FROM THE FDA IN OUR REGULATORY DEPARTMENT ON (B)(6), 2013, THE CUSTOMER ALLEGED THAT A "CHILD UNDERWENT IR PROCEDURE THAT RESULTED IN AN UNANTICIPATED NEUROLOGIC OUTCOME AS A RESULT OF AN EQUIPMENT FAILURE." THE DATE OF EVENT ON THE CUSTOMER'S REPORT, (B)(6) 2013, IS THE SAME DATE OF EVENT AS ON THE COMPLAINT RECEIVED BY SIEMENS. HOWEVER, ACCORDING TO THE CUSTOMER'S MDR, THE PRODUCT CODE - "(RA)-SYSTEM, RADIATION THERAPY, CHARGED PARTICLE, MEDICAL (LHN)" IS UNRELATED TO THE EQUIPMENT MENTIONED IN THE SIEMENS COMPLAINT. ALSO, THE SECTION "DEVICE TYPE:" IN THE CUSTOMER'S REPORT STATES "FLUKE V 451P SURVEY METER". THIS IS NOT THE SIEMENS SYSTEM TYPE INSTALLED AT THE SITE (WHICH IS THE AXIOM ARTIS ZEE BIPLANE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137682 AXIOM ARTIS ZEE BIPLANE SYSTEM, X-RAY, ANGIOGRAPHIC IZI SIEMENS AG 10094141

    Patients

    Seq Age Sex Outcome Treatment
    1 11 Other