BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ONE

    MDR report key: 19164465 · Received April 23, 2024

    Report

    Report Number
    3004754211-2024-00002
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    April 15, 2024
    Report Date
    June 18, 2024
    Manufacturer
    SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.
    Product Code
    OWB
    UDI-DI
    04056869009964
    PMA / PMN Number
    K133580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEFECTIVE TUBE WAS RETURNED FOR FURTHER ANALYSIS. THE INVESTIGATION SHOWED THAT THE INDUCTIVITY VALUE OF THE LARGE FOCUS (F2) WAS IN THE RANGE OF THE SPECIFICATION WITH 12.96 MICROHENRIES BUT THE INDUCTIVITY VALUE OF THE SMALL FOCUS (F1) WAS NOT AS EXPECTED WITH 13.9 MICROHENRIES. AFTER DISASSEMBLING THE TUBE INSERT, IT WAS CONFIRMED THAT THE SMALL EMITTER (F1) WAS TOUCHING THE FOCAL HEAD. ADDITIONALLY, IT WAS DETERMINED THAT THE FOCAL TRACK WAS OVERLOADED. SINCE THE OPERATION TIME OF THIS X-RAY TUBE ASSEMBLY (XTA) WAS TWENTY MONTHS WITH A LOAD VALUE OF 37489 LU, AN EMITTER WEAR-OUT IS CONSIDERED TOO SHORT AND IT IS NOT WITHIN THE NORMAL RANGE OF THE EXPECTED LIFETIME. ACCORDING TO SUPPLIER ANALYSIS, NO SYSTEMATIC ISSUE ARE IDENTIFIED AT THIS POINT OF TIME AND NO FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 0

    SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENT. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE PROVIDED LOG FILES WAS COMPLETED WITH THE FOLLOWING RESULTS. THE LOG DATED (B)(6) 2024, SHOWED THAT PATIENT REGISTRATION WAS DONE AT 15:16:53, AND X-RAY RELEASE WAS PERFORMED AT 15:51:28. AFTER 12 FLUOROS AND 2 ACQUISITIONS, MULTIPLE AX_PUD 20502 EVENTS IN THE LOG INDICATED TUBE ARCING THAT STARTED AT 15:58:53. AT 15:59:57, ¿DOSE LESS THAN 5%¿ ERROR WAS LOGGED ONCE. X-RAY RELEASE WAS CONTINUED ALONG WITH THE ABOVE-MENTIONED ERRORS. AT 16:20:00 EVERY X-RAY WITH SMALL FOCUS WAS ABORTED WITH AN ERROR ¿DOSE LESS THAN 5%¿; TUBE CURRENT AND DOSE WERE ALMOST AT 0. THE SYSTEM WAS POWERED OFF/ON AT 16:24:03/ 16:27:44. THE USER ATTEMPTED 3 FLUOROS AND 3 ACQUISITIONS BUT THE ISSUE FOR THE X-RAY RELEASE WITH SMALL FOCUS PERSISTED. SIEMENS LOCAL SERVICE ENGINEER INSPECTED THE UNIT THE NEXT DAY, AND CONFIRMED THE ISSUE WAS CAUSED BY THE TUBE. THE TUBE WAS REPLACED TUBE AND THE SYSTEM WAS BROUGHT BACK TO NORMAL OPERATION. THE DEFECTIVE TUBE WAS RETURNED FOR FURTHER ANALYSIS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED FOLLOWING TUBE INVESTIGATION.

    Description of Event or Problem · 0

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ONE SYSTEM. SMALL FOCUS X-RAY IMAGING WAS NOT POSSIBLE DURING AN EMERGENCY CARDIOLOGY PROCEDURE. PATIENT WAS RELOCATED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED ON AN ALTERNATE UNIT. SIEMENS IS UNAWARE OF ANY HEALTH CONSEQUENCES TO THE INVOLVED PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328605 ARTIS ONE INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. 10848600 04056869009964

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown