BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERA 1.5T PULSAR

    MDR report key: 1132825 · Received August 21, 2008

    Report

    Report Number
    1217116-2008-00062
    Event Type
    Other
    Date Received
    August 21, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 22, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED UPON NOTIFICATION FROM OUR MR MFR OF AN EVENT THAT OCCURRED. PROBLEM: A PT WAS UNDER ANESTHETIC AND SCANNED WITH THE SYNERGY SPINE COIL WHILE THE PT WAS USING A THIRD PARTY ECG-LEADS (TESLA PLUS FROM MIPM). AFTER THE EXAMINATION, THE CONNECTION BETWEEN AN ECG ELECTRODE AND THE ECG LEAD WAS VERY HOT. ALSO, IT HAD A MELTED ECG CLIP. A THIRD DEGREE BURN APPEARED UNDER THIS ECG ELECTRODE LOCATED AT THE CHEST POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERA 1.5T PULSAR LNH (MAGNETIC RESONANCE DIAGNOSTIC DEVICE) LNH PHILIPS MEDICAL SYSTEMS 781105 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other