BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM ARTIS DFC

    MDR report key: 1618662 · Received February 25, 2010

    Report

    Report Number
    2240869-2010-00002
    Event Type
    Injury
    Date Received
    February 25, 2010
    Date of Event
    November 12, 2009
    Report Date
    February 3, 2010
    Manufacturer
    SIEMENS AG
    Product Code
    KPR
    PMA / PMN Number
    K052202
    Removal / Correction Number
    2240869-02/25/10-002-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT COULD BE DUPLICATED AFTER RECEIVING THE CONCERNED COLLIMATOR. THE PLANNED MEASURE SOLVES THE PROBLEM. INFO WILL BE AVAILABLE TO THE SERVICE ORGANIZATION THROUGH A SYSTEM UPDATE. ALL SERVICE ORGANIZATIONS IN COUNTRIES WITH INSTALLED VOLUMN WILL BE ASKED TO INFORM STAFF TO INSTALL AN ADDITIONAL MODIFIED GROUNDING PIECE WHENEVER A COLLIMATOR IS EXCHANGED. IMPLEMENTATION OF FINAL CORRECTIVE MEASURE ((B) (4)). TOTAL INSTALLED VOLUME WILL RECEIVE ADDITIONAL GROUNDING, REGARDLESS OF A COLLIMATOR REPLACEMENT. (B) (6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EXAM, THE SYSTEM FAILED DUE TO A COLLIMATOR PROBLEM. THE FEMALE PT SUFFERED A HEART ATTACK BUT IT COULD NOT BE DETERMINED WHETHER THE HEART ATTACK WAS THE RESULT OF A DEVICE PROBLEM OR DUE TO THE PT'S CONDITION. THE POWER UNIT AND THE COLLIMATOR WERE REPLACED AT THE CUSTOMER'S SITE. THIS EVENT OCCURRED IN (B) (6). AFTER BECOMING AWARE OF THE PROBLEM A SIMULATION WAS PERFORMED. IT WAS CONFIRMED THAT UNSATISFACTORY GROUNDING MIGHT CAUSE THE PROBLEM AND THAT PROPER GROUNDING WILL BE THE SOLUTION. THE PROBLEM CAN ONLY OCCUR AFTER CHANGING THE COLLIMATOR DURING A SERVICE INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOM ARTIS DFC SYSTEM, X-RAY, ANGIOGRAPHIC KPR SIEMENS AG 07412807 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O| R