BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ONE

    MDR report key: 18392652 · Received December 26, 2023

    Report

    Report Number
    3004754211-2023-00007
    Event Type
    Malfunction
    Date Received
    December 26, 2023
    Date of Event
    December 20, 2023
    Report Date
    July 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
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: SIEMENS HEALTHINEERS COMPLETED THE INVESTIGATION OF THE REPORTED ISSUE. THE INVESTIGATION WAS PERFORMED BASED ON EXPERT DISCUSSIONS CONSIDERING COMPLAINT DESCRIPTION, CUSTOMER SERVICE REPORTS, AND SYSTEM HISTORY, AND SYSTEM LOG FILES ANALYSIS. ACCORDING TO THE INITIALLY PROVIDED INFORMATION, NO X-RAY WAS POSSIBLE DURING AN EMERGENCY PROCEDURE. THE PATIENT WAS RELOCATED TO ANOTHER SYSTEM FOR COMPLETION OF THE PROCEDURE. NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT WERE COMMUNICATED TO SIEMENS HEATHINEERS. IT IS CONCLUDED THAT THE RELAY IN HOSPITAL POWER SUPPLY CONTROL CABINET WAS MALFUNCTIONING AND CAUSED A LACK OF POWER TO THE GENERATOR, RESULTING IN NO X-RAY EXPOSURE FROM THE SYSTEM. SYSTEM WAS BACK TO FULL FUNCTIONALITY AFTER HOSPITAL TECHNICIAN EXCHANGED THE DEFECTIVE RELAY. NO SYSTEM MALFUNCTIONS OR NON-CONFORMITIES HAVE BEEN IDENTIFIED. THE SYSTEM WORKED AS SPECIFIED. NO FURTHER ACTIONS ARE NECESSARY. H11 CORRECTED DATA: H6: THE MEDICAL DEVICE PROBLEM CODE REPORTED IN THE INITIAL MDR SUBMITTED ON DECEMBER 26, 2023, SHOULD HAVE BEEN 4027. CODE 4042 WAS REPORTED IN ERROR. H6: THE MEDICAL DEVICE PROBLEM CODE REPORTED IN THE INITIAL MDR SUBMITTED ON DECEMBER 26, 2023, SHOULD HAVE BEEN 4027. CODE 4042 WAS REPORTED IN ERROR.

    Additional Manufacturer Narrative · 0

    ON 7/18/2024, SUPPLEMENTAL MDR 2 WAS SUBMITTED TO THE FDA FOR CORRECTION OF THE PRIMARY UDI NUMBER IN SECTION D4.

    Additional Manufacturer Narrative · 0

    E1: (B)(6). H6: SIEMENS HEALTHINEERS HAS INITIATED A DETAILED INVESTIGATION OF THE COMPLAINT EVENT AND SYSTEM. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED UPON THE COMPLETION OF THE INVESTIGATION. H6: COMPONENT CODE 4756 WAS UTILIZED BECAUSE IT IS UNKNOWN AS OF THE DATE OF THIS REPORT WHICH SYSTEM COMPONENT ATTRIBUTED TO THE COMPLAINT EVENT.

    Description of Event or Problem · 0

    SIEMENS HEALTHINEERS WAS INFORMED BY ITS SERVICE ORGANIZATION REGARDING A MALFUNCTION ASSOCIATED WITH THE ARTIS ONE SYSTEM. IT WAS STATED THAT NO X-RAY WAS POSSIBLE DURING AN EMERGENCY PROCEDURE. THE PATIENT WAS RELOCATED TO ANOTHER SYSTEM FOR COMPLETION OF THE PROCEDURE. NO ADVERSE HEALTH CONSEQUENCE TO THE PATIENT WAS COMMUNICATED TO SIEMENS HEALTHINEERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361366 ARTIS ONE INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. 10848600 04056869009964

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown