BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 1275228 · Received December 19, 2008

    Report

    Report Number
    3003768277-2008-00053
    Event Type
    Other
    Date Received
    December 19, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    LNH
    PMA / PMN Number
    k052013
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ALL BENCH TESTS PERFORMED ON THIS COIL, EXCEPT FOR THE FAILED CABLE BALUN, SUPPORT A WORKING COIL. THE CABLE BALUN FAILED DUE TO RANDOM COMPONENT FAILURE. ALSO, HIGH SAR LEVELS WERE USED RESULTING IN WARNING MESSAGES FOR THE OPERATOR. THESE MESSAGES WERE ACCEPTED BY THE OPERATOR AND THE SCANS WITH HIGH SAR WERE CONTINUED ON THE PT. THE CAPACITOR FAILURE IN COMBINATION WITH INSUFFICIENT DISTANCE BETWEEN COIL CABLE AND PT AND THE HIGH SAR VALUES POSSIBLY CAUSED THE BURN. THE INSTRUCTIONS FOR USE CONTAINS WARNINGS ON COIL AND CABLE POSITIONING IN RELATIONSHIP TO THE PT.

    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