BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTIS ONE

    MDR report key: 12793609 · Received November 11, 2021

    Report

    Report Number
    3004754211-2021-03877
    Event Type
    Death
    Date Received
    November 11, 2021
    Date of Event
    October 27, 2021
    Report Date
    November 11, 2021
    Manufacturer
    SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.
    Product Code
    OWB
    UDI-DI
    04056869009964
    PMA / PMN Number
    K133580
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. ASSESSMENT DOES NOT INDICATE A SYSTEM FAILURE OR MALFUNCTION AND NO NON-CONFORMITY WAS IDENTIFIED. THE EVENT LOGFILE ANALYSIS ON (B)(6) 2021 SHOWED THAT THE SYSTEM WAS STARTED AT 07:38 AND THE PATIENT WAS CREATED AT 08:28. EXAMINATION WAS FROM 8:50 TO 11:33 WITH FL/ACQ. NO BYPASS AND NO ERRORS WERE FOUND. A SIEMENS SERVICE ENGINEER WAS ONSITE TO CHECK THE SYSTEM FUNCTIONALITY AND THE AFFECTED PARTS BY THE FIRE. SEVERAL FIRE MARKS WERE SEEN ON THE TABLE COVERS, LOWER BODY RADIATION PROTECTION AND EHC CABLE. THE SYSTEM WAS WORKING WELL FROM A TECHNICAL POINT OF VIEW. THE AFFECTED PARTS HAVE BEEN REPLACED FOR THIS SYSTEM. THE AFFECTED PARTS (TABLE COVERS, LOWER BODY RADIATION PROTECTION AND EHC CABLE) ARE DESIGNED WITH NONFLAMMABLE MATERIALS. IN THIS CASE, ONLY MINOR FIRE MARKS WERE ON THE SURFACES OF THE AFFECTED PARTS WITHOUT FURTHER FIRE SPREAD WHILE SYSTEM FUNCTIONALITY WAS NOT AFFECTED. THE CUSTOMER DID NOT RAISE ANY COMPLAINTS FOR THE ARTIS ONE SYSTEM DURING THIS CASE AND CONFIRMED THAT THE SYSTEM DID NOT CONTRIBUTE/LEAD TO THE PATIENT DEATH. IT WAS CONCLUDED THAT NO MALFUNCTION OCCURRED. THE ARTIS ONE SYSTEM DID NOT CAUSE/CONTRIBUTE TO THE FIRE NOR TO THE PATIENT DEATH, WHICH THE CAUSAL RELATIONSHIP BETWEEN SERIOUS INCIDENT AND THE SYSTEM HAVE NOT BEEN ESTABLISHED.

    Additional Manufacturer Narrative · 0

    SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENTS. AT THIS TIME, THERE IS NO CAUSALITY BETWEEN THE SYSTEM ERROR AND THE PATIENT'S DEATH. 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 · 0

    IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE ARTIS ONE SYSTEM. THE USER REPORTED THAT A FIRE OCCURRED ON THE SYSTEM TABLE DURING PATIENT TREATMENT. THE USER ALSO REPORTED THAT THE FIRE WAS NOT DUE TO A SYSTEM FAILURE. IT WAS LATER REPORTED THAT THE PATIENT PASSED AWAY. 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
    1697476 ARTIS ONE INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. 10848600 04056869009964

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death