BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ARTIS DBC

    MDR report key: 6438574 · Received March 28, 2017

    Report

    Report Number
    2240869-2017-01507
    Event Type
    Malfunction
    Date Received
    March 28, 2017
    Date of Event
    March 3, 2017
    Report Date
    March 3, 2017
    Manufacturer
    SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY
    Product Code
    OWB
    PMA / PMN Number
    K052202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE PROBLEM OCCURRED DUE TO A FAILURE OF THE BSR (IMAGE SYSTEM X-RAY). THE MAIN PC OF THE BSR FAILED AND NO IMAGING WAS AVAILABLE ON THE LIVE MONITOR OR ON THE CONTROL MONITOR. THE CLINICAL PROCEDURE COULD BE CONTINUED AND FINISHED USING THE WORKPLACE MONITOR. THE SHORT TERM DELAY DID NOT RESULT IN A NEGATIVE IMPACT TO THE HEALTH OF THE PATIENT INVOLVED. EXCHANGE OF THE BSR PC WAS PERFORMED AND THE SYSTEM HAS BEEN RETURNED TO CLINICAL OPERATION. FAILURE OF THE BSR IS BEING MONITORED VIA THE CAPA PROCESS. IN CASE OF AN INCREASE, FURTHER ACTIONS ARE TO BE CONSIDERED.

    Additional Manufacturer Narrative · 1

    SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENTS. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE AXIOM ARTIS DBC SYSTEM. DURING A CLINICAL PROCEDURE, THE X-RAY IMAGE WAS NOT SHOWN ON THE LIVE MONITOR IN THE EXAMINATION ROOM AND WAS ONLY VISIBLE ON THE WORKPLACE MONITOR. THE PROCEDURE WAS CONTINUED AND WAS COMPLETED USING THE WORKPLACE MONITOR. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220659 AXIOM ARTIS DBC INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY 07728392

    Patients

    Seq Age Sex Outcome Treatment
    1