BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERA 1.5T

    MDR report key: 1586327 · Received January 18, 2010

    Report

    Report Number
    3003768277-2010-00009
    Event Type
    Other
    Date Received
    January 18, 2010
    Date of Event
    November 25, 2009
    Report Date
    November 25, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LNH
    PMA / PMN Number
    K052013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD, RESULTS, CONCLUSION: THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED UPON NOTIFICATION FROM OUR MR MFR IN (B)(4), TO SUBMIT THIS EVENT THAT HAPPENED IN (B)(6). PROBLEM: PT HAD A MR EXAM WITH THE QUADRATURE BODY COIL. THE SENSE BODY COIL 1.5T WAS CONNECTED BUT NOT USED DURING THE EXAMINATION. THE PT SAID SHE FELT HEATING SENSATIONS DURING THE WHOLE EXAMINATION. HOWEVER, SHE DIDN'T PRESS THE ALARM BUTTON UNTIL 35 MINS INTO THE EXAMINATION. AFTER PRESSING THE ALARM BUTTON, THE EXAMINATION WAS CONTINUED FOR ANOTHER 26 MINS OF WHICH 22 MINS USED A MAXIMUM SAR VALUE. THE PT ENDED UP WITH SECOND DEGREEN BURNS. THE PT RECEIVED TREATMENT OF BURNED AREAS: COOLED WITH ICE, WIPED WITH SALINE, COVERING THE TWO BLISTERS (1 X 4 CM) WITH TULL GRASS AND TEGADERMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERA 1.5T LNH (MAGNETIC RESONANCE DIAGNOSTIC DEVICE) LNH PHILIPS MEDICAL SYSTEMS 781172 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other