BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS DFC

    MDR report key: 3587975 · Received October 15, 2013

    Report

    Report Number
    2240869-2013-08778
    Event Type
    Malfunction
    Date Received
    October 15, 2013
    Date of Event
    September 27, 2013
    Report Date
    September 30, 2013
    Manufacturer
    SIEMENS AG
    Product Code
    JAA
    PMA / PMN Number
    K052202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THIS POTENTIAL COMPLAINT IS ONGOING AND A ROOT CAUSE HAS NOT YET BEEN DETERMINED. SIEMENS WILL FILE A SUPPLEMENTAL REPORT ONCE A FULL INVESTIGATION HAS BEEN COMPLETED AND ROOT CAUSE ANALYSIS HAS BEEN DETERMINED. THIS INCIDENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IT WAS COMMUNICATED THAT DURING A NEURO PROCEDURE, THE ARTIS DFC SYSTEM LOCKED UP CAUSING A DELAY IN PROCEDURE. THE SYSTEM OPERATOR PERFORMED A SYSTEM REBOOT AND THE SYSTEM WAS THEN FUNCTIONING PROPERLY. WE ARE UNAWARE OF ANY INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528468 ARTIS DFC INTERVENTIONAL, FLUOROSCOPIC XRAY JAA SIEMENS AG 07412807

    Patients

    Seq Age Sex Outcome Treatment
    1