BEUDAMED
    FDA Adverse Event Other Summary report: N

    1.5T HDX ECHOSPEED

    MDR report key: 1730097 · Received June 17, 2010

    Report

    Report Number
    2183553-2010-00020
    Event Type
    Other
    Date Received
    June 17, 2010
    Date of Event
    May 27, 2010
    Report Date
    May 27, 2010
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION CONSISTED OF AN EVAL OF THE MR SYSTEM'S PERFORMANCE AND A LABELING REVIEW. PRELIMINARY SYSTEM TESTS AND INSPECTION PERFORMED BY THE FIELD ENGINEER DEMONSTRATED THAT THE MR SYSTEM WAS PERFORMING WITHIN SPECIFICATIONS, AND NO EVIDENCE OF MALFUNCTION OCCURRED THAT CAUSED OR CONTRIBUTED TO THE FLAME'S IGNITION. THE MR SYSTEM'S OPERATOR MANUAL PROVIDES GENERAL SAFETY INSTRUCTIONS REGARDING WARNING AND A SPECIFIC WARNING TO THE USERS AGAINST THE USE OF NON-COMPATIBLE STEREOTACTIC FRAMES AND RF BLANKETS. A NOTIFICATION OF THE EVENT WAS SENT TO THE MANUFACTURER OF THE BLANKET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN MRI EXAM OF THE ANKLE, FLAMES DEVELOPED ON THE PT'S SCRUB PANTS UNDER AN RF BLANKET. THE CUSTOMER SITE USED RF BLANKET TO COVER THE UNAFFECTED PART OF THE PT'S LEG. REALIZING THE EVENT, THE PT NOTIFIED THE TECHNOLOGIST AND ATTEMPTED TO PUT OUT THE FLAMES. THE TECHNOLOGIST STOPPED THE SCAN AND REMOVED THE PT FROM THE MAGNET BORE. AFTER THE FLAMES WERE EXTINGUISHED, A DEPARTMENT NURSE EXAMINED THE PT AND NOTED THAT THE SKIN WAS SLIGHTLY PINK, AND SEVERAL HAIRS WERE SINGED. THE NURSED INDICATED THAT SHE DID NOT CONSIDER THIS A FIRST-DEGREE BURN SINCE SHE BELIEVED THAT THE SKIN WAS PINK DUE TO THE HEAT AND SKIN TONE OF THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5T HDX ECHOSPEED LNH GE MEDICAL SYSTEMS, LLC 2294302

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other RF BLANKET MANUFACTURED BY (B)(6)