BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHILIPS INTERA MRI MACHINE

    MDR report key: 539631 · Received April 19, 2004

    Report

    Report Number
    539631
    Event Type
    Other
    Date Received
    April 19, 2004
    Date of Event
    September 1, 2003
    Report Date
    September 1, 2003
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC./MRI DIVISION
    Product Code
    LNH
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ENTERED INTO MRI (MAGNETIC RESONANCE IMAGING) SCANNER, FOR A MRI OF THE BRAIN. UPON BEGINNING OF 3RD SEQUENCE, PT STARTED THRASHING (ABOUT 5 SECS). SCAN STOPPED AND PT REMOVED FROM MAGNET. PT STATED ARM WAS BURNING. THE BODY (ARM) COULD HAVE TOUCHED THE SIDE OF THE MACHINE. THE NICOTINE PATCH WAS NOT SEEN AT THE TIME OF THE SCAN. EXAM BY A RADIOLOGY PHYSICIAN NOTED THE PT'S UPPER LEFT ARM WAS MILDLY ERYTHEMATOUS AND THERE WAS A SMALL DENUDED BLISTER. THE BURN, THE SIZE OF A TIP OF AN ERASER, OBLONG AND SMALLER THAN THE NICOTINE PATCH THE PT HAD ON THEIR ARM. INFO FROM: PHARMACY DIRECTOR: NICOTINE TRANSDERMAL PATCH, 21MGS, ROUND. THE NICOTINE PATCH WAS THE ONLY PATCH ON THE PT AT THE TIME OF THE MRI, AND HAS BEEN DISCONTINUED EARLIER THE MORNING IN 2003. THE SITE OF THE NICOTINE PATCH WAS ROTATED AND IT WAS PLACED DAILY. THERE HAD BEEN NO CHANGES IN THE DOSE OF THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS INTERA MRI MACHINE MRI SCANNER LNH PHILIPS MEDICAL SYSTEMS, INC./MRI DIVISION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other NO OTHER. NICOTINE PATCH (TRANSDERMAL).