BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSHIBA

    MDR report key: 4182408 · Received October 17, 2014

    Report

    Report Number
    2020563-2014-00003
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BURN WAS ALLEGEDLY CAUSED BY A SKIN TO SKIN LOOP FROM THE BREAST TOUCHING THE CHEST. THE PATIENT WAS WEARING A HOSPITAL GOWN AND THERE WAS PAD BETWEEN COIL AND PATIENT'S CHEST.. THE CABLE WAS ROUTED STRAIGHT WITH NO LOOPS AND PATIENT WAS NOT TOUCHING THE COIL OR THE BORE WALL. ALLEGEDLY THE BURN IS SLIGHTLY SMALLER THAN A QUARTER, BETWEEN FIRST AND SECOND DEGREE PER THE REVIEWING PHYSICIAN. COILS WERE CHECKED AND THERE WAS NO APPARENT DEFECT AND NO DAMAGE WAS NOTED. A QUALITY ASSURANCE CHECK WAS CONDUCTED FOR THE COILS (I.E., SIGNAL TO NOISE AND ALL COIL SET UP CHECKS) AND THEY PASSED.

    Description of Event or Problem · 1

    PATIENT RECEIVED RF BURN FROM SKIN TO SKIN CONTACT BETWEEN BREAST AND CHEST DURING ABDOMINAL MRI STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661795 TOSHIBA MAGNETIC RESONANCE IMAGING SYSTEM LNH TOSHIBA MEDICAL SYSTEMS CORPORATION MRT-1504/S3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other