BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM ARTIS ZEE

    MDR report key: 2003223 · Received February 28, 2011

    Report

    Report Number
    2240869-2011-22804
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IZI
    PMA / PMN Number
    K073290
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS REPORTED AS THE RESULT OF A CUSTOMER REQUEST FOR A SYSTEM INSPECTION BY TECHNICAL SERVICE, (B)(6) 2011. A COMPLAINT WAS FILED AFTER TESTING AND EVALUATION OF THE SYSTEM, AS A COMPLAINT ON (B)(6) 2011. COMPLAINT TEXT: "CUSTOMER CALLED TO HAVE DOSE CHECKED ON SYSTEM BECAUSE THEY HAD RADIATED A PATIENT FOR TO [SIC] LONG AND WANTED TO BE SURE READINGS WERE CORRECT BEFORE REPORTING INCIDENT TO PROPER AUTHORITY." THE SYSTEM WAS INSPECTED AND TESTED ON (B)(4) 2011, AND PASSED SUCCESSFULLY. IT WAS DETERMINED THAT THE SYSTEM IS "WORKING ACCORDING TO SPECIFICATION". WHEN THE ABOVE MENTIONED COMPLAINT REPORT WAS RECEIVED BY THE MANUFACTURER, THE EVENT WAS CONSIDERED AS POTENTIAL ADVERSE EVENT. A SYSTEM TEST PERFORMED (B)(4), 2011, AND AGAIN ON (B)(4), 2011. THE SAME CONCLUSION WAS REACHED; THE SYSTEM IS WORKING AS SPECIFIED OVER TIME. SYSTEM LOG FILES FROM THE DATE OF EVENT HAVE BEEN EVALUATED WITHOUT ANY INDICATION OF IRREGULARITY. NO CAUSAL RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE COULD BE DETERMINED.

    Description of Event or Problem · 1

    THIS IS TO REPORT AN EVENT REGARDING A HIGH DOSE APPLICATION AND POTENTIAL IMPACT TO THE STATE OF HEALTH OF ONE PATIENT. IT WAS REPORTED IN THE INITIAL PHYSICIST'S REPORT THAT A HEART CATHETERIZATION PROCEDURE WAS DONE ON A PATIENT THAT EVENTUALLY HAD A TOTAL OF 183.9 MINUTES OF FLUOROSCOPY TIME FROM THE "A" PLANE X-RAY TUBE AND 164 MINUTES FROM THE "B" PLANE X-RAY TUBE. ADDITIONALLY, THERE WAS 153 SECONDS OF CINE FROM THE "A" PLANE AND 152 SECONDS FROM THE "B" PLANE. THE HOSPITAL'S PHYSICIST / SAFETY OFFICER, (B)(6), UPON NOTIFICATION DETERMINED THAT THERE WAS A POTENTIAL SENTINEL EVENT (AS DEFINED BY JOINT COMMISSION STANDARDS). SIEMENS SERVICE ENGINEER WAS REQUESTED AT THE CUSTOMER SITE TO CHECK THE MAXIMUM DOSE RATES WITH THE PHYSICIST TO DETERMINE WHETHER THE SYSTEM WAS OPERATING WITHIN SPECIFICATIONS. SIEMENS SERVICE DETERMINED THAT THE SYSTEM WAS OPERATING WITHIN SPECIFICATIONS. ALSO, ACCORDING TO THE PHYSICIST'S REPORT, THE APPARENT MAXIMUM DOSE DELIVERED TO THE SKIN FROM THE "A" PLANE TUBE IS 13.7 GY, AND THE FROM THE "B" PLANE TUBE IS 12.4 GY. THIS DOES NOT EXCEED THE JOINT COMMISSION STANDARD OF 15 GY / FIELD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening