BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHIEVA 1.5T NEW

    MDR report key: 6198475 · Received December 22, 2016

    Report

    Report Number
    3003768277-2016-00119
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    November 8, 2016
    Report Date
    November 28, 2016
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K063559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE PROVIDED INFORMATION AND TESTS PERFORMED ON SITE, THERE IS NO INDICATION OF A MALFUNCTION OF THE MRI SYSTEM OR COIL USED THAT CONTRIBUTED TO THE INJURY. IN THIS CASE, THE REPORTED SKIN REDDENING DEVELOPED INTO SKIN NECROSIS AFTER THE EXAMINATION. THIS INDICATES THAT THE INJURY WAS NOT A DIRECT THERMAL INJURY (THE CABLE DIDN¿T BECOME TOO HOT TO TOUCH). THE INJURY IS EXPECTED TO BE AN RF BURN, CAUSED BY THE LOOP BETWEEN THE PATIENT¿S BODY AND THE COIL CABLE. NO PADDING WAS USED BETWEEN THE COIL CABLE AND THE BODY TO ENSURE SUFFICIENT DISTANCE AS PRESCRIBED IN THE INSTRUCTIONS FOR USE. THE HIGH ADMINISTERED RF ENERGY DOSE (SAR X SCAN TIME) CONTRIBUTED TO THE SEVERITY OF THE HEATING INCIDENT.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A REPORT FROM A CUSTOMER RELATED TO A 3RD DEGREE HEATING INCIDENT. THE PATIENT WAS SCANNED ON AN ACHIEVA 1.5T SYSTEM WITH THE SENSE KNEE COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850940 ACHIEVA 1.5T NEW SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH PHILIPS HEALTHCARE 781296

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other