BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 1132923 · Received August 21, 2008

    Report

    Report Number
    3003768277-2008-00026
    Event Type
    Other
    Date Received
    August 21, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    LNH
    PMA / PMN Number
    K001796
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: THE ECG MONITORING EQUIPMENT (TESLA PLUS, MIPM, MAMMENDORF, EKG) USED DURING THE MR EXAMINATION WAS NOT PROVIDED BY PHILIPS HEALTHCARE. ALTHOUGH THIS EQUIPMENT IS MARKED AS MR COMPATIBLE, THE TESLA PLUS WAS NEVER TESTED OR RELEASED FOR A PHILIPS MR SYSTEM. ALSO, IT'S BEEN OBSERVED THAT 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, WHICH MAY HAVE CONTRIBUTED TO THE HEATING UP OF THE ECG LEADS. THESE KINDS OF INCIDENTS CAN BE PREVENTED BY USING ECG LEADS PROVIDED BY PHILIPS HEALTHCARE AND FOLLOWING THE INSTRUCTIONS FOR USE (IFU). THE INSTRUCTIONS FOR USE ALREADY CONTAIN WARNINGS TO ONLY USE ECG LEADS PROVIDED BY PHILIPS HEALTHCARE. THE USE OF OTHER TYPES OF ECG LEADS MAY CAUSE HEATING OF THE SKIN. THIS INCIDENT REPORT WILL BE FORWARDED TO THE MFR OF THE TESLA PLUS MONITORING EQUIPMENT.

    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