BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA ARTIST

    MDR report key: 16786184 · Received April 21, 2023

    Report

    Report Number
    3010949642-2023-00002
    Event Type
    Injury
    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, 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.

    Additional Manufacturer Narrative · 0

    BASED ON ADDITIONAL EVENT INFORMATION RECEIVED, THE PATIENT DID NOT HAVE AN IMPLANTED MR CONDITIONAL DEFIBRILLATOR OR PACEMAKER AND WAS SUCCESSFULLY RESUSCITATED. THE MR SCANNER DID NOT CONTRIBUTE TO ANY PATIENT EVENT. THIS EVENT IS CONSIDERED NON-REPORTABLE. H3: BASED ON ADDITIONAL EVENT INFORMATION RECEIVED, THE PATIENT DID NOT HAVE AN IMPLANTED MR CONDITIONAL DEFIBRILLATOR OR PACEMAKER AND WAS SUCCESSFULLY RESUSCITATED. THE MR SCANNER DID NOT CONTRIBUTE TO ANY PATIENT EVENT. THIS EVENT IS CONSIDERED NON-REPORTABLE.

    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. THE PATIENT WAS ABLE TO BE RESUSCITATED.

    Description of Event or Problem · 0

    GE HEALTHCARE WAS INFORMED BY THE CUSTOMER THAT THIS PATIENT DID NOT HAVE AN IMPLANTED MR CONDITIONAL DEFIBRILLATOR OR PACEMAKER. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT WAS SUCCESSFULLY RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964545 SIGNA ARTIST NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE (TIANJIN) COMPANY LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening