BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 1258664 · Received December 1, 2008

    Report

    Report Number
    3003768277-2008-00050
    Event Type
    Other
    Date Received
    December 1, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    LNH
    PMA / PMN Number
    K030520
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    (CONCLUSIONS)-(OTHER) - THE PT HEATING WAS MOST LIKELY CAUSED BY UNWANTED RF INTERFERENCE. THE FACT THAT INSUFFICIENT DISTANCE WAS KEPT BETWEEN CABLE AND PT AND THE HIGH SAR LEVELS MAY HAVE CONTRIBUTED TO THE BURN. THE INSTRUCTIONS FOR USE ALREADY CONTAINS WARNINGS ABOUT CABLE POSITIONING. ALSO, DEPENDING OF THE POSITION OF THE COIL AND THE PT THIS COULD LEAD TO HEATING OF THE COIL CABLE OR ELEMENTS AND/OR UNWANTED RF INTERFERENCE. SUCH INTERFERENCE IS HARD TO PREDICT, BECAUSE WITH RF INTERFERENCE MANY FACTORS PLAY A ROLE, 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 AND CABLES RELATED TO THE PT, THE SCAN TECHNIQUES USED, AND ETC. THE SAME COIL MAY CONTRIBUTE TO AN RF BURN IN ONE EXAM, BUT WILL NOT LEAD TO A BURN IN MANY OTHER EXAMS ON 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 *