BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 1252644 · Received November 20, 2008

    Report

    Report Number
    3003768277-2008-00046
    Event Type
    Other
    Date Received
    November 20, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    LNH
    PMA / PMN Number
    k001796
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS - THE COIL CABLE WAS ROUTED BETWEEN THE MAGNET AND THE PT'S LEG. THIS COULD POSSIBLY RESULT IN INSUFFICIENT DISTANCE BETWEEN THE COIL CABLE AND THE PT'S LEG. THE GENERATED CABLE HEAT THEN COULD NOT DISSIPATE OFF THE PT. THE OPERATOR STATED THAT THE COIL CABLE WAS TOO WARM TO TOUCH. MOST LIKELY THE BURN IS A RESULT OF UNWANTED RF INTERFACE. SUCH INTERFACE IS HARD TO PREDICT BECAUSE WITH RF INTERFACE, MANY FACTORS PLAY A ROLE WHICH INCLUDE, BUT NOT LIMITED TO: THE POSITION OF THE PT IN THE BORE, THE CONDITION OF THE PT, THE POSITION OF THE COIL IN THE BORE, THE POSITION OF THE COIL CABLES RELATED TO THE PT, THE SCAN TECHNIQUES USED, AND ETC. THE SAME COIL MAY CONTRIBUTE TO AN RF BURN IN ONE EXAMINATION, BUT WILL NOT LEAD TO A BURN IN MANY OTHER EXAMINATIONS AT THE SAME SITE. NOTE THE INDICATED IMPORTER HAS REC'D FDA EXEMPTION # TO SUBMIT ONE FDA FORM 3500A TO SATISFY BOTH THE IMPORTER (803.42) AND MFR (803.52) FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * LNH PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. * *

    Patients

    Seq Age Sex Outcome Treatment
    1