BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS MEDICAL SYSTEMS NORTH AMERICA

    MDR report key: 1916496 · Received November 24, 2010

    Report

    Report Number
    MW5018330
    Event Type
    Injury
    Date Received
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA
    Product Code
    LNH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BURNS ASSOCIATED WITH MRI SCANNING. PHILIPS MEDICAL SYSTEMS NORTH AMERICA. MRI OF THE LEFT HUMERUS. THE PT COMPLAINED OF A HOT SENSATION ON HIS ARM DURING THE SCAN. THE SCAN WAS STOPPED AND RESUMED AFTER ADDITIONAL PADDING WAS ADDED BETWEEN THE PT AND THE COIL. FOUR DAYS AFTER THE MRI, THE PT REPORTED THE DEVELOPMENT OF BLISTERS ON HIS ARM IN THE AREA SCANNED. THE SERVICE TECHNICIAN NOTED BROWN MARKS ON THE MRI SYNERGY CARDIAC COILS, WHICH WERE REPLACED. MRI OF THE RIGHT HIP. ADDITIONAL PADDING USED WITH THE PHILIPS 5 CHANNEL SYNERGY CARDIAC COIL. BLISTERS NOTED 1 HOUR AFTER THE SCAN. PT DEVELOPED A SECOND DEGREE AND THIRD DEGREE BURN; REQUIRED MEDICAL AND SURGICAL INTERVENTION. COIL TAKEN OUT OF SERVICE AND REPLACED BY PHILIPS. NEAR MISS EVENT. ADDITIONAL FOAM PAD APPLIED BETWEEN THE PT'S SKIN AND THE SYNERGY BODY COIL FOR AN MRI OF THE HIP. THE FOAM BURNED AND MELTED DUE TO THE HEAT CREATED BY THE COIL'S RF CABLE. NO INJURY TO THE PT. THE MRI WAS TAKEN OUT OF THE SERVICE. COIL REPLACED AND TESTED. NEAR MISS EVENT. THE PT COMPLAINED OF A WARM SENSATION WHEN AN MRI SCAN STARTED. THE MRI HAS BEEN TAKEN OUT OF SERVICE UNTIL FURTHER NOTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS MEDICAL SYSTEMS NORTH AMERICA INTERA 1.5 T MASTER/NOVA. SYNERGY CARDIAC COIL ACS-NT LNH PHILIPS MEDICAL SYSTEMS NORTH AMERICA
    2 PHILIPS MEDICAL SYSTEMS NORTH AMERICA INTERA 1.5T MASTER/NOVA SYNERGY CARDIAC COIL ACS-NT -CZ- SYNERGY BODY COIL 1.5 T LNH PHILIPS MEDICAL SYSTEMS NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other