BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ARTIS ZEEGP

    MDR report key: 3931748 · Received April 15, 2014

    Report

    Report Number
    2240869-2014-09363
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    October 8, 2013
    Report Date
    March 4, 2014
    Manufacturer
    SIEMENS AG
    Product Code
    IZI
    PMA / PMN Number
    K073290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED WITH THE FDA ON 03/10/2014. INITIAL ASSESSMENT OF THE ISSUE ON (B)(4) 2013 WAS DEEMED A NON-REPORTABLE EVENT. FOLLOWING THE COMPLETION OF A FULL INVESTIGATION OF RESULTS, AND ROOT CAUSE ANALYSIS ON 03/04/2013, THIS EVENT IS NOW CONSIDERED TO BE A REPORTABLE EVENT AS THE POTENTIAL EXISTS FOR SYSTEM MALFUNCTION AND DELAY OF PROCEDURE. TO DATE, NO INFORMATION REGARDING PATIENT INJURY OR INJURY TO SYSTEM OPERATORS HAS BEEN REPORTED.

    Description of Event or Problem · 1

    SIEMENS BECAME AWARE OF A SPORADIC FAILURE WHEN A PROCEDURE WAS CANCELED IN ITS EARLY STAGES AND THE PATIENT WAS RELOCATED TO ANOTHER SYSTEM. WE ARE UNAWARE OF ANY INJURY TO THE PATIENT OR OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231367 AXIOM ARTIS ZEEGP SYSTEM, XRAY, ANGIOGRAPHIC IZI SIEMENS AG 10280959

    Patients

    Seq Age Sex Outcome Treatment
    1