BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA VOYAGER

    MDR report key: 19264377 · Received May 7, 2024

    Report

    Report Number
    3010949642-2024-00001
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    March 28, 2024
    Report Date
    June 21, 2024
    Manufacturer
    GE HEALTHCARE (TIANJIN) COMPANY LIMITED
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION REQUESTED BUT NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    B4; G1, 3, 6; H2, 3, 6. H3: GE HEALTHCARE (GEHC) INVESTIGATION HAS BEEN COMPLETED. A PATIENT, WHO WAS ON THE TABLE IN THE SCAN ROOM, WAS INJURED WHEN THEIR ANKLE WEIGHTS WITH METAL BUCKLES AND FILLED WITH METAL BALLS BECAME ATTRACTED TO THE MAGNET. THE TECHNICIAN NOTICED THE ANKLE WEIGHTS BUT THOUGHT THAT THEY WERE FILLED WITH SAND AND NOT METAL BALLS. THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR. GEHC'S OPERATOR MANUAL WITH INTEGRATED SAFETY SECTION, WHICH IS PROVIDED TO THE CUSTOMER, CLEARLY DEFINES THE RISKS ASSOCIATED WITH OWNING AND OPERATING AN MR SCANNER. NO FURTHER ACTIONS ARE PLANNED BY GEHC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO AN MR EXAM, A PATIENT WHO WAS ON THE TABLE WAS WEARING ANKLE WEIGHTS WITH METAL BUCKLES AND FILLED WITH METAL BALLS WHEN THEIR LEG BECAME BENT WHEN IT WAS ATTRACTED TO THE MAGNET. THE CUSTOMER QUENCHED THE MAGNET TO REMOVE THE MAGNETIC FIELD, BUT THE PATIENT STILL SUFFERED FEMORAL NECK AND PELVIC FRACTURES. THE CUSTOMER REFUSED TO PROVIDE ANY DETAILS OF THE MEDICAL TREATMENT THAT WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621749 SIGNA VOYAGER NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE (TIANJIN) COMPANY LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention