BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTIS ONE

    MDR report key: 8811143 · Received July 22, 2019

    Report

    Report Number
    3004754211-2019-87875
    Event Type
    Injury
    Date Received
    July 22, 2019
    Date of Event
    May 2, 2019
    Report Date
    June 29, 2019
    Manufacturer
    SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.
    Product Code
    OWB
    PMA / PMN Number
    K133580
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. ASSESSMENT OF THE LOG FILES DOES NOT INDICATE A SYSTEM FAILURE OR MALFUNCTION AND NO NON-CONFORMITY WAS IDENTIFIED. LOG FILES FROM MAY 04 TO MAY 14 WERE ANALYZED WHICH SHOWED THE SYSTEM WAS WORKING NORMALLY WHILE THE NEUROLOGICAL OGP DOSE SETTING DURING THIS PERIOD WAS SET TO THE DEFAULT SETTING. A CEREBRAL EMBOLIZATION PROCEDURE LASTING 2 HOURS IS SENSIBLE, AND THE KNOWN SIDE-EFFECT OF EPILATION (DESCRIBED IN USER MANUAL) IS ALSO POSSIBLE DURING SUCH PROCEDURES. IT IS A POSSIBLE LATENCY X-RAY EXPOSURE EFFECT, HOWEVER, IT DEPENDS ON THE IMAGING PRACTICES [OGP(S) (FLUORO & ACQ), FRAME (DOSE PER PULSE, F/R, P/R,), ZOOM SIZE (FOV), COLLIMATION, FOCUS (SMALL & LARGE)], SYSTEM TECHNICAL STATUS, PROCEDURE TIME (THE LONGER PROCEDURE TIME, THE MORE EXPOSURE) AND INDIVIDUAL X-RAY RADIATION TOLERANCE. THERE IS NO INDICATION OF A SYSTEM FAILURE, MALFUNCTION OR NON-CONFORMITY. NO FURTHER ACTIONS ARE TO BE TAKEN AS THERE IS NO NEGATIVE AWARENESS IN REGARDS TO THE QUALITY AND PERFORMANCE OF THE SYSTEM.

    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 AN ADVERSE EVENT OCCURRED FOLLOWING EXAMINATION ON THE ARTIS ONE SYSTEM. ON (B)(6) 2019 A PATIENT UNDERWENT A CEREBRAL EMBOLIZATION WHICH LASTED APPROXIMATELY 2 HOURS. ON (B)(6) 2019, THE PATIENT NOTIFIED THE MEDICAL FACILITY OF HAIR LOSS ON THE HEAD ONE MONTH AFTER TREATMENT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607647 ARTIS ONE INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. 10848600

    Patients

    Seq Age Sex Outcome Treatment
    1 Other