BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMRIS HC300 IOHV2 HEAD FLEX COIL

    MDR report key: 8414797 · Received March 12, 2019

    Report

    Report Number
    3010326005-2019-00003
    Event Type
    Injury
    Date Received
    March 12, 2019
    Date of Event
    February 13, 2019
    Report Date
    March 12, 2019
    Manufacturer
    DEERFIELD IMAGING, INC.
    Product Code
    MOS
    PMA / PMN Number
    K103506
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEAD COIL IN QUESTION IS IN THE ROOT CAUSE EVALUATION STAGE AND INVESTIGATION IS ON-GOING AS TO WHETHER THE PATIENT BURN WAS CAUSED BY THE FLEX COIL, OR PERSONNEL NOT FOLLOWING INSTRUCTIONS FOR USE, OR OTHER REASONS. A FOLLOW-UP REPORT SHALL BE SUBMITTED ONCE SUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE THE SERIOUSNESS OF THE PATIENT BURN AND THE ROOT CAUSE EVALUATION.

    Description of Event or Problem · 1

    A PATIENT EXPERIENCED A BURN ON HIS LEFT FOREARM, APPROXIMATELY 5CM X 2 CM, DURING A PROCEDURE. THE BURN WAS NOT DISCOVERED UNTIL AFTER THE CASE AND WAS REPORTED TO IMRIS PERSONNEL AS SOON AS IT WAS DETERMINED THAT IT MOST LIKELY OCCURRED FROM THE MR SCAN DURING THE PROCEDURE. THE MRI OR DIRECTOR STATED THAT SHE WAS NOT AWARE OF ANY MEDICAL INTERVENTION REQUIRED REGARDING THE BURN OR HOW THE HOSPITAL CLASSIFIED THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206236 IMRIS HC300 IOHV2 HEAD FLEX COIL HEAD IMAGING COIL MOS DEERFIELD IMAGING, INC. HC300 IOHV2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR