BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE BIPLANE

    MDR report key: 6405585 · Received March 15, 2017

    Report

    Report Number
    2240869-2017-71163
    Event Type
    Malfunction
    Date Received
    March 15, 2017
    Date of Event
    February 16, 2017
    Report Date
    February 16, 2017
    Manufacturer
    SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY
    Product Code
    IZI
    PMA / PMN Number
    K073290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE INVESTIGATION DOES NOT SHOW A MALFUNCTION OR DETERIORATION IN THE CHARACTERISTICS OR PERFORMANCE OF THE DEVICE AND THE SYSTEM WORKS AS INTENDED. FOR INVESTIGATION, SIEMENS RECEIVED IMAGE DATA FOR 14 SERIES (59 DICOM FILES + STUDY REPORT). ALL ACQUISITIONS WERE TRANSFERRED IN FULL RESOLUTION AND BIT DEPTH. HOWEVER, ALL FLUORO SCENES WERE DOWNSIZED TO A RESOLUTION OF 512X512 WITH 8-BIT DEPTH CAUSING A REDUCED IMAGE QUALITY. THE ACQUISITIONS (SERIES 1-4 AND 6) HAVE BEEN ACQUIRED WITH OGP ARCH (~3MGY/P, 4HZ, SMALL FOCUS). THE FIRST FLUORO SERIES (SERIES 5, 9, AND 10) HAVE BEEN ACQUIRED WITH OGP FL(-) NEURO (29NGY/P, 7.5HZ, SMALL FOCUS). LATER FLUOROS (SERIES 11, 13, AND 14) HAVE BEEN ACQUIRED WITH OGP FL(-) ANGIO (32NGY/P, 7.5HZ, SMALL FOCUS). SOME SINGLE SHOTS (SERIES 7, 8, AND 12) HAVE BEEN ACQUIRED WITH OGP SINGLE (1820NGY/P, SMALL FOCUS). THE TRANSFERRED IMAGE DATA HAS BEEN ACQUIRED WITH OGPS THAT ARE; WITH RESPECT TO DETECTOR DOSE AND FRAMERATE; GENERALLY SUITABLE FOR IMAGING DURING AN EMBOLECTOMY. HOWEVER, ROADMAP MAY HAVE BEEN A GENERAL ALTERNATIVE TO NATIVE FLUORO. IN ADDITION, THERE IS NO INDICATION THAT THE IMAGE QUALITY IN FLUORO WAS RATED AS INSUFFICIENT, AS NO ATTEMPT TO CHANGE THE FLUORO PROGRAM FROM (-) TO NORMAL OR EVEN (+) IS DOCUMENTED. IN SEVERAL SCENES THE IMAGE QUALITY IS DEGRADED BY PATIENT MOTION CAUSING SEVERE SUBTRACTION ARTIFACTS IN DSA (E.G. SERIES 3, 6). APART FROM THESE PATIENT MOVEMENTS, THE IMAGE QUALITY IS NOT REMARKABLE. IT IS ADEQUATE FOR THE CHOSEN OGPS AND DOES NOT SHOW ANY TECHNICAL ARTIFACTS WHICH HEAVILY DEGRADE THE IMAGE QUALITY. THE IMAGE QUALITY ANALYSIS OF FLUORO IMAGES IS LIMITED DUE TO THE IMAGE DOWNSIZING. AFTER EVALUATION BY THE IMAGE QUALITY DEPARTMENT, NEITHER A SYSTEM FAILURE NOR A SYSTEM MALFUNCTION COULD BE DETERMINED. THE TRANSFERRED IMAGE DATA GIVES NO INDICATION OF A TECHNICAL MALFUNCTION WHICH MIGHT HAVE SEVERELY DEGRADED THE IMAGE QUALITY IN GENERAL.

    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 ZEE BIPLANE SYSTEM. DURING A CLINICAL PROCEDURE, THE CUSTOMER REPORTED THE A AND B PLANE ACQUISITION IMAGES WERE PIXELATED AND BLURRY, HOWEVER, FLUORO WAS USABLE ON BOTH PLANES. 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
    187524 ARTIS ZEE BIPLANE SYSTEM, X-RAY, ANGIOGRAPHIC IZI SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY 10094141

    Patients

    Seq Age Sex Outcome Treatment
    1