BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMRIS NEURO III-SV INTRA-OPERATIVE MRI SYSTEM

    MDR report key: 18628484 · Received February 1, 2024

    Report

    Report Number
    3010326005-2024-00002
    Event Type
    Injury
    Date Received
    February 1, 2024
    Date of Event
    January 2, 2024
    Report Date
    February 1, 2024
    Manufacturer
    IMRIS - DEERFIELD IMAGING, INC.
    Product Code
    LNH
    PMA / PMN Number
    K083137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A MANUFACTURER SERVICE ENGINEER INVESTIGATED ON-SITE ON 2024-01-03 AND 2024-01-04, WHICH IS WHEN THE MANUFACTURER WAS MADE AWARE OF THE PATIENT'S INVOLVEMENT. INVESTIGATION ON-SITE FOUND THERE WAS NO MALFUNCTION IN THE MRI MOVER SYSTEM. THE MAGNET WAS REPORTEDLY IN TRANSIT AWAY FROM IMAGING POSITION PER USER CONTROLS WHEN THE LIGHT BOOM ATTRACTED TO THE MAGNET BORE. ATTRACTION OF FERROMAGNETIC OBJECTS IS AN INHERENT PROPERTY AND RISK IN USE OF MRI. MANUFACTURER CONTACTED THE MANUFACTURER OF THE LIGHT BOOM INVOLVED FOR THEIR AWARENESS AND ASSESSMENT. FURTHER DETAILS RELATED TO THE SEQUENCE OF EVENTS AND PATIENT IMPACT HAVE BEEN REQUESTED BY THE MANUFACTURER BUT NOT PROVIDED TO DATE. THE ROOT CAUSE IS NOT DETERMINED AT THIS TIME, A FOLLOWUP REPORT IS PLANNED PENDING FURTHER INFORMATION.

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS WERE MADE TO GATHER ADDITIONAL INFORMATION ON THE EVENT REPORTED AND DETAILS SURROUNDING PATIENT IMPACT. THE CUSTOMER RESPONDED THAT THEY WOULD NOT DISCLOSE FURTHER INFORMATION PENDING CONTACT WITH THEIR INTERNAL LEGAL OFFICE. THE CLINICAL AND HEALTH IMPACT CODES SELECTED IN THE MDR REFLECT MANUFACTURER'S LIMITED KNOWLEDGE AFTER ATTEMPTING TO GATHER FURTHER INFORMATION ON PATIENT IMPACT. AN IMRIS SERVICE ENGINEER INVESTIGATED THE SYSTEM WHILE ON-SITE AND FOUND NO MALFUNCTION IN THE MRI MOVER SYSTEM. PRIOR PREVENTIVE MAINTENANCE RECORDS WERE REVIEWED AND SUPPORT ABSENCE OF ANY FUNCTIONAL ISSUES OR ANOMALIES THAT COULD POTENTIALLY RELATE TO THE REPORTED EVENT. BASED ON AVAILABLE INFORMATION THE PROBABLE CAUSE IS INADVERTENT USER ERROR IN POSITIONING A FERROMAGNETIC OBJECT TOO CLOSE TO THE MRI MAGNET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USING THE MR MAGNET IN AN INTRA-OPERATIVE PROCEDURE, DURING THE STEPS TO RETURN THE MAGNET TO ITS HOME POSITION, A NEARBY LIGHT BOOM ATTRACTED TOWARDS THE MAGNET BORE. A PATIENT WAS ON THE OPERATING ROOM TABLE AND WAS REPORTED TO BE STRUCK BY THE LIGHT BOOM, CAUSING A LACERATION. FURTHER DETAILS ON THE EVENT HAVE BEEN REQUESTED BY THE MANUFACTURER WITH NO FURTHER DETAIL PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278873 IMRIS NEURO III-SV INTRA-OPERATIVE MRI SYSTEM MAGNETIC RESONANCE IMAGING LNH IMRIS - DEERFIELD IMAGING, INC. 105117-004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other