BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSHIBA

    MDR report key: 3867460 · Received June 11, 2014

    Report

    Report Number
    2020563-2014-00001
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 15, 2014
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Product Code
    MOS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS INVESTIGATED THIS ISSUE AND HAS DETERMINED THE CAUSE WAS THE PLACEMENT OF THE COIL CABLE. IT WAS FOUND THAT THE COIL CABLE, PATIENT'S BODY AND ARM BECAME AN RF LOOP WITH CAPACITANCE. RF CURRENT FLOWED THRU THE CAPACITIVE LOOP BETWEEN THE COIL CABLE AND THE PATIENT'S ARM. FOAM PADS SHOULD BE USED INSTEAD OF THE TOWEL THAT WAS USED BETWEEN THE COIL AND THE PATIENT'S ARM. DATA FOR THE COIL AND THE RF TRANSMISSION WERE REVIEWED BY THE MANUFACTURER AFTER THE PROBLEM OCCURRED AND WAS FOUND TO BE NORMAL. THE MANUAL FOR THE COIL CONTAINS THE FOLLOWING CAUTION STATEMENTS: ROUTE THE CABLE THAT CONNECTS THE ANTERIOR AND POSTERIOR UNITS OF THE COIL PROPERLY SO THAT IT DOES NOT COME INTO CONTACT WITH THE PATIENT. IF CONTACT IS UNAVOIDABLE, FOAM PADS WITH A COMPRESSED THICKNESS OF 1 CM SHOULD BE PLACED BETWEEN THE CABLE AND THE PATIENT. DIRECT CONTACT CAN RESULT IN BURNS. IF THE PATIENT'S ARM OR SHOULDER OR THE ANTERIOR UNT OF THE QD TORSO SPEEDER COMES INTO DIRECT CONTACT WITH THE QD WHOLE BODY COIL (INNER WALL OF THE MAGNET ASSEMBLY), FOAM PADS WITH A COMPRESSED THICKNESS OF 1 CM SHOULD BE PLACED BETWEEN THE QD WHOLE-BODY COIL AND THE PATIENT OR THE ANTERIOR UNIT. DIRECT CONTACT CAN RESULT IN BURNS.

    Additional Manufacturer Narrative · 1

    DURING AN MRI EXAM, A PATIENT ALLEGEDLY COMPLAINED THAT THE COIL CABLE WAS GETTING HOT. PRIOR TO THE START OF THE EXAM, THE TECHNOLOGIST WRAPPED THE COIL CABLE IN A TOWEL SO THAT IT WOULD NOT BE IN DIRECT CONTACT WITH THE PATIENT. THE TECHNOLOGIST ALLEGEDLY STATED THAT SHE PUT A SECOND TOWEL BETWEEN THE PATIENT AND THE COIL CABLE AND THE HEAT LESSENED. ONCE THE EXAM WAS COMPLETED, THE TECHNOLOGIST LOOKED AT THE PATIENT'S ARM AND FOUND THAT HE HAD A RED MARK ON HIS FOREARM WHERE THE CABLE HAD BEEN RESTING. WHEN THE PATIENT ARRIVED HOME, HE SAID THAT A BLISTER HAD FORMED. THE NEXT DAY THE PATIENT SAID THAT THE BLISTER HAD POPPED AND THAT HE WOULD NOTIFY THEM OF ANY CHANGE. THE COIL IS BEING RETURNED TO THE MANUFACTURER FOR EVALUATION. NO RESULTS SINCE EVALUATION HAS NOT BEGUN.

    Description of Event or Problem · 1

    A PATIENT ALLEGEDLY SUFFERED A SKIN BURN/BLISTER APPROXIMATELY THE SIZE OF A DIME AND A NICKEL DURING AN MRI EXAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344589 TOSHIBA MAGNETIC RESONANCE COIL MOS TOSHIBA MEDICAL SYSTEMS CORPORATION MJAB-137A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other