BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA HORIZON CX AKA MR/I

    MDR report key: 3378182 · Received September 25, 2013

    Report

    Report Number
    2183553-2013-00030
    Event Type
    Injury
    Date Received
    September 25, 2013
    Date of Event
    August 17, 2013
    Report Date
    August 27, 2013
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K962061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE HAS DECLINED TO PROVIDE ANY ADDITIONAL PATIENT INFORMATION. AN MR SYSTEM USED ELECTROMAGNETIC ENERGY TO PRODUCE CLINICALLY DIAGNOSTIC IMAGES. THE RADIO FREQUENCY (RF) FIELD IS AN OSCILLATING ELECTROMAGNETIC FIELD. PULSES OF RF ENERGY ARE USED TO GENERATE THE SIGNAL, WHICH CAUSE TISSUES TO ABSORB RF POWER. UNDER CERTAIN CONDITIONS, THIS MAY CAUSE TISSUE HEATING. THE AMOUNT OF HEATING DEPENDS ON SEVERAL FACTORS, SUCH AS PATIENT SIZE AND PULSE SEQUENCE TIMING. RF HEATING OF TISSUES IS GREATEST AT THE PERIPHERY OF THE SKIN. THE SPECIFIC ABSORPTION RATE (SAR) IS THE ESTIMATE AMOUNT OF HEAT DOSE RECEIVED BY THE PATIENT. THIS VALUE IS EXPRESSED AS WATTS OF POWER PER KILOGRAM OF THE PATIENT'S BODY WEIGHT. HUMANS SUBJECTED TO SIGNIFICANT RADIO FREQUENCY POWER DEPOSITION (I.E., SIGNIFICANT SAR) WILL NORMALLY ATTEMPT TO DISSIPATE THE ADDITIONAL HEAT LOAD THROUGH VASODILATATION OF SKIN BLOOD VESSELS PERMITTING SKIN TO APPROACH CORE TEMPERATURE. THIS ACTION TYPICALLY CAUSES THE SKIN TO FLUSH (TURN RED) AND ENABLES THE BODY TO DISSIPATE HEAT MORE RAPIDLY. THIS SKIN FLUSHING IS A NORMAL RESPONSE TO SIGNIFICANT RADIO FREQUENCY POWER DEPOSITION. SKIN REDDENING OR TO A LESSER DEGREE THE REPORT OF A WARMING SENSATION WITHOUT REDDENING REGARDLESS OF THE METHOD IT WAS CREATED (SAR, CONTACT, METAL, ETC) IS NOT HAZARDOUS IF IT CLEARS IN A FEW HOURS. THE MR SAFETY GUIDE, WHICH IS DELIVERED TO THE CUSTOMER AT THE TIME OF SYSTEM TURNOVER, CLEARLY DISCUSS IN-DEPTH, THE EFFECTS OF ELECTROMAGNETIC FIELDS ON THE PATIENT, AS WELL AS THE HAZARDS AND MITIGATIONS TO ENSURE PATIENT SAFETY. IT IS ULTIMATELY THE RESPONSIBILITY OF THE OPERATOR TO FULLY SCREEN PATIENTS PRIOR TO THEIR EXAM, AND TO MONITOR THE PATIENT'S WELLBEING DURING AN MR EXAM. PATIENTS WHO ARE SEDATED OR INCAPACITATED MAY MAKE MONITORING MORE DIFFICULT, AS THEY MAY NOT BE ABLE TO ALERT THE OPERATOR TO UNUSUAL WARMING SENSATIONS. OTHER FACTORS WHICH MAY MAKE PATIENT MONITORING DIFFICULT MAY INCLUDE COMPROMISING MEDICAL CONDITIONS THAT AFFECT THE BODY'S ABILITY TO REGULATE TEMPERATURE OR DISSIPATE HEAT, OR UNDISCLOSED OR UNDETECTED CONDITIONS WHICH MAY CONCENTRATE THE RF ENERGY, OR COMPROMISE THE BODY'S THERMOREGULATORY SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS UNDERGOING A MR SCAN OF THE LEFT KNEE. PADDING WAS REPORTEDLY USED INSIDE OF THE COIL TO HELP KEEP THE PATIENT STILL. NO PADDING WAS USED OUTSIDE OF THE COILS AS THE PATIENT WAS REPORTEDLY NOT TOUCHING THE BORE. IT IS NOT KNOWN IF THE PATIENT'S RIGHT KNEE WAS TOUCHING THE OUTSIDE OF THE COIL. THE PATIENT WAS REPORTEDLY TAKING PAIN MEDICATION AT THE TIME OF THE SCAN AND NOTED NO PAIN DURING THE SCAN. HOWEVER, LATER THAT DAY THE PATIENT DID REPORT EXPERIENCING PAIN WHEN THE PATIENT'S KNEE WAS INADVERTENTLY HIT BY ANOTHER INDIVIDUAL WHILE SWIMMING. IT WAS THEN THAT AN AREA ADJACENT TO THE PATELLA ON THE INSIDE OF THE PATIENT'S RIGHT KNEE APPEARED TO BE A BURNED. THE FOLLOWING MONDAY, THE PATIENT SAW A DERMATOLOGIST AND IT WAS NOTED THAT THE WOUND HAD FORMED A BLISTER. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND SILVADENE OINTMENT TO APPLY TO THE BURNED AREA. THE AREA OF THE BURN WAS ESTIMATED TO BE THE SIZE OF A QUARTER ACCORDING TO THE MR SUPERVISOR. SEVERAL DAYS LATER, THE MR SUPERVISOR CONTACTED THE PATIENT AND THE PATIENT CONFIRMED THAT THE AREA HAD WORSENED AND HAD DEVELOPED INTO AN "OPEN WOUND". THE PATIENT HAS REPORTEDLY SEEN THE DERMATOLOGIST A SECOND TIME, BUT NO ADDITIONAL INFORMATION WAS MADE AVAILABLE. THE SITE REPORTEDLY WILL NOT BE PROVIDING ANY ADDITIONAL INFORMATION REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485147 SIGNA HORIZON CX AKA MR/I MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other