BEUDAMED
    FDA Adverse Event Summary report: N

    PHILIPS 1.5T MRI

    MDR report key: 891032 · Received July 12, 2007

    Report

    Report Number
    891032
    Date Received
    July 12, 2007
    Date of Event
    June 18, 2007
    Report Date
    July 12, 2007
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LNH
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED THAT HE WAS BURNED BY A "HOT" WIRE UNDER HIS WRIST DURING AN MRI SCAN. THE RADIOLOGY TECH TOOK THE PATIENT OUT OF THE TUBE TO ASSESS HIM AND DID NOT SEE EVIDENCE OF ANY BURN. THE PATIENT WAS RE-WRAPPED WITH THE SHEET AND PLACED BACK INTO THE CYLINDER. THE PATIENT REPORTED AGAIN FEELING BURNED, AND AT THE COMPLETION OF THE STUDY, REPORTED HIS COMPLAINT TO THE NURSE ON HIS UNIT. AN AREA OF REDNESS 5 CM BY 2CM WAS NOTED ON HIS RIGHT WRIST, AND THIS RESOLVED WITH LOTION. PHILLIPS STAFF WERE NOTIFIED TO CHECK THE MACHINE. OF NOTE, THE PATIENT BODY HABITUS WAS UPPER LIMIT FOR MRI ACCESSIBILITY WHICH MAY HAVE CONTRIBUTED TO THE PROXIMITY OF THE COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILIPS 1.5T MRI MRI LNH PHILIPS MEDICAL SYSTEMS 43000-588 *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR