BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 1085186 · Received June 13, 2008

    Report

    Report Number
    3003768277-2008-00011
    Event Type
    Other
    Date Received
    June 13, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    LNH
    PMA / PMN Number
    K030520
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: THE DISTANCE BETWEEN COIL AND PT WAS INSUFFICIENT AT THE PLACE OF THE BURN (2 MM). ALSO, HIGH SAR LEVELS WERE USED RESULTING IN WARNING MESSAGES FOR THE USER. THESE MESSAGES WERE ACCEPTED BY THE USER AND THE SCANS WITH HIGH SAR WERE CONTINUED. THESE KINDS OF INCIDENTS CAN BE PREVENTED AS MUCH AS POSSIBLE BY FOLLOWING THE INSTRUCTIONS FOR USE. IN THIS CASE, THERE WAS INSUFFICIENT DISTANCE BETWEEN THE CABLE AND THE PT. THE INSTRUCTIONS FOR USE, SECTION 2.18.10 ALREADY CONTAINS WARNINGS. SINCE THIS TYPE OF USER ERROR HAS BEEN REPORTED SEVERAL TIMES, A NEW SPECIAL SLEEVE IS TO BE MOUNTED OVER THE CABLE. THE SLEEVE FORCES THE CABLES TO HAVE SUFFICIENT DISTANCE FROM THE ANATOMY, WHICH SHOULD REDUCE THE RF INTERACTION. THIS SLEEVE HAS BEEN INTRODUCED FOR NEW TORSO XL COILS RECENTLY AND WILL BE ISSUED AS FIELD CHANGE ORDER.

    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