BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G.E.

    MDR report key: 342199 · Received June 28, 2001

    Report

    Report Number
    MW1022390
    Event Type
    Injury
    Date Received
    June 28, 2001
    Date of Event
    June 23, 2001
    Report Date
    June 26, 2001
    Manufacturer
    G.E. MEDICAL SERVICES
    Product Code
    LNH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVING MRI SCAN OF LEFT WRIST WHEN SUPPORT IGNITED FROM INSIDE. PT IMMEDIATELY REMOVED FROM MRI, WRIST AND FOREARM RINSED WITH COOL RUNNING WATER. TECHNOLOGIST REMOVED THE COIL AND SPONGE FROM THE BORE OF THE MAGNET AND FLAME EXTINGUISHED. MRI OUT OF SVC UNTIL GE REP RESPONDED AND REVIEWED EQUIPMENT FOR SAFETY ON SAME DAY. PT REPORTS SINGED HAIR, NECK AND LEFT WRIST STRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29782 G.E. MRI LNH G.E. MEDICAL SERVICES 1.5 TELSA UNIT, TFX *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention