BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIGNA ARTIST

    MDR report key: 16786307 · Received April 21, 2023

    Report

    Report Number
    3010949642-2023-00003
    Event Type
    Death
    Date Received
    April 21, 2023
    Date of Event
    March 23, 2023
    Report Date
    June 9, 2023
    Manufacturer
    GE HEALTHCARE (TIANJIN) COMPANY LIMITED
    Product Code
    LNH
    PMA / PMN Number
    K163331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1, 2, 3, 4; B4, 7; G1, 3, 6; H2, 3, 6 H3: GE HEALTHCARE'S (GEHC) INVESTIGATION HAS BEEN COMPLETED. THE GEHC FIELD ENGINEER CONFIRMED THAT REQUIRED MAGNETIC FIELD WARNING SIGNAGE WAS IN PLACE ON MR SCAN ROOM DOORS, PREVENTATIVE MAINTENANCE (PMS) WERE UP TO DATE FOR THE SYSTEM AND SYSTEM PERFORMANCE TESTS WERE MEETING SPECIFICATION PRIOR TO THE PATIENT¿¿S SCAN. THE SIGNA ARTIST OPERATOR MANUAL SAFETY SECTION PROVIDES INFORMATION ON PROPER PATIENT SCREENING AND CLINICAL EVALUATION OF PATIENTS WITH IMPLANTED DEVICES ALONG WITH HELP TO DETERMINE WHETHER MR CONDITIONAL CRITERIA ARE MET. GEHC WAS NOT PROVIDED WITH SUFFICIENT EVIDENCE TO PROVE APPROPRIATE CLINICAL DECISIONS WERE MADE, APPROPRIATE MR CONDITIONS WERE MET, OR THE PATIENT¿¿S PHYSICAL CONDITION WOULD ALLOW FOR A SAFE MR SCAN. THEREFORE, THE MOST LIKELY ROOT CAUSE IS IDENTIFIED AS INAPPROPRIATE CLINICAL DECISION BASED ON THE LIMITED AVAILABLE INFORMATION BUT CANNOT BE CONFIRMED. NO FURTHER ACTIONS ARE PLANNED BY GEHC.

    Additional Manufacturer Narrative · 0

    A1,2, 3, 4, 5, 6: PATIENT INFORMATION WAS REQUESTED ON 3/25/2023, 3/30/2023, 4/6/2023, 4/10/2023, 4/18/2023 AND 4/19/2023 BUT NO INFORMATION HAS BEEN RECEIVED. D4 UNIQUE IDENTIFIER: (B)(4). D: THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. H3, 6: GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. H3 OTHER TEXT : DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS SCANNED WITH AN IMPLANTED DEFIBRILLATOR. DURING THE SCAN, THE PATIENT WENT INTO CARDIAC ARREST. RESUSCITATION WAS ATTEMPTED, BUT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685116 SIGNA ARTIST NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE (TIANJIN) COMPANY LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Death