BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ICONO BIPLANE

    MDR report key: 9871203 · Received March 24, 2020

    Report

    Report Number
    3004977335-2020-22766
    Event Type
    Malfunction
    Date Received
    March 24, 2020
    Date of Event
    February 25, 2020
    Report Date
    March 9, 2020
    Manufacturer
    SIEMENS HEALTHCARE GMBH- AT
    Product Code
    OWB
    PMA / PMN Number
    K190768
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE WAS DETERMINED TO BE A SOFTWARE ERROR. THE INVESTIGATION SHOWED THAT THE ISSUE IS CAUSED BY A INTEROPERABILITY SOFTWARE PROBLEM. AS A RESULT, THE QUANTIFICATION ON SOME DSA IMAGES (NOT ALL) SENT FROM THE ARTIS ICONO SYSTEM TO THE WORKSTATION QUANT XWP STANDALONE DOESN´T WORK OR PRODUCES NON-RELIABLE RESULTS. THE ISSUE IS RELATED TO DSA IMAGES FROM ARTIS ICONO VE20 ONLY. IT DOES NOT APPLY FOR OTHER IMAGE MODES (E.G. CARD, NATIVE/DR). THE ERROR WILL BE CORRECTED WITH A SOFTWARE UPDATE (AX034/20/S) OF THE QUANTIFICATION APPLICATION (E.G. QVA/QCA) ON DSA IMAGES. CORRECTION FOR THIS FAILURE WILL BE REPORTED TO THE FDA UNDER 21 CFR 806 UPON RELEASE. THIS CORRECTIVE ACTION WILL ELIMINATE THE ROOT CAUSE OF THE PROBLEM AND PREVENTS THE POSSIBILITY OF REOCCURRENCE. AFTER DETAILED INVESTIGATION, THE INCIDENT IS NOT CLASSIFIED AS A REPORTABLE EVENT AS NEITHER SERIOUS INJURY, DEATH NOR AN UNEXPECTED PROLONGED HOSPITALIZATION OF THE PATIENT OR ANY OTHER PERSON OCCURRED OR COULD BE EXPECTED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ICONO BIPLANE SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE DSA IMAGES SENT FROM THE ICONO TO THE QUANT XWP STAND ALONE WERE NOT AS EXPECTED. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336447 ARTIS ICONO BIPLANE INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH- AT 11327600

    Patients

    Seq Age Sex Outcome Treatment
    1