BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMRIS HC300 IOHV2 HEAD FLEX COIL

    MDR report key: 13440837 · Received February 3, 2022

    Report

    Report Number
    3010326005-2019-00028
    Event Type
    Injury
    Date Received
    February 3, 2022
    Date of Event
    August 27, 2019
    Report Date
    August 27, 2019
    Manufacturer
    IMRIS - DEERFIELD IMAGING, INC
    Product Code
    MOS
    UDI-DI
    00857534006226
    PMA / PMN Number
    K103506
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BURN TO THE PATIENT'S FOREHEAD APPEARED TO HAVE BEEN CAUSED BY THE MR-CONDITIONAL MEDTRONIC AXIEM STEALTH ARRAY DEVICE THAT WAS APPLIED TO THE PATIENT'S FOREHEAD PRIOR TO AND DURING INTRAOPERATIVE SCANNING. THIS WAS THE HOSPITAL OR STAFF'S CONCLUSION. A FLEX COIL INVOLVED IN THE PROCEDURE WAS RETURNED FOR EVALUATION. IT WAS FUNCTIONALLY TESTED/ INSPECTED AND FOUND THAT THE SIGNAL TO NOISE RATIO DID NOT MEET SPECIFICATION. IT APPEARED THAT THE COIL HAD BEEN DROPPED BECAUSE THERE THE PRE-AMPS WERE FOUND TO BE LOOSE. IT WAS CONCLUDED THAT, ALTHOUGH THE COIL DID NOT MEET SNR, IT DID NOT CONTRIBUTE TO THE BURN ON THE PATIENT'S FOREHEAD.

    Description of Event or Problem · 0

    A NEUROLOGICAL PROCEDURE WITH INTRAOPERATIVE SCAN TOOK PLACE ON A (B)(6) MONTH OLD PEDIATRIC PATIENT. AFTER THE MRI SCAN WAS COMPLETED AND THE PATIENT WAS UNDRAPED, A FULL-THICKNESS BURN WAS NOTED TO THE PATIENT'S FOREHEAD. PER THE HOSPITAL AND THEIR INVESTIGATION, IT WAS DETERMINED THAT THE CAUSE OF THE BURN WAS A MEDTRONIC MR CONDITIONAL AXIEM STEALTH ARRAY THAT WAS IN PLACE ON THE PATIENT'S FOREHEAD. THERE WERE TWO FACTORS INVOLVED IN THE BURN: FIRST, THERE WAS A DISCONNECT BETWEEN THE OR AND THE MR TECHNICIAN THAT THE DEVICE WAS IN USE AND STILL ON THE PATIENT'S FOREHEAD PRIOR TO AND DURING THE SCAN; SECONDLY, THE INSTRUCTIONS FOR USE FOR THE MEDTRONIC ARRAY WAS NOT FOLLOWED FOR USE WITHIN AN MRI, THUS CREATING A FULL-THICKNESS BURN TO THE PATIENT'S FOREHEAD BY THE UNCOILED WIRE THAT CONNECTS TO THE ARRAY. AT THE TIME OF THE SCAN, IMRIS FLEX COILS WERE BEING UTILIZED HOWEVER; THERE DOES NOT APPEAR TO BE ANY RELATIONSHIP BETWEEN THE IMRIS COMPONENTS AND THE PATIENT BURN. A HOSPITAL STAFF REPORTED THE INCIDENT TO MEDTRONIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372200 IMRIS HC300 IOHV2 HEAD FLEX COIL MAGNETIC RESONANCE IMAGING COILS MOS IMRIS - DEERFIELD IMAGING, INC HC300 00857534006226

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Unknown Other