BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T SIGNA HDX ECHOSPEED

    MDR report key: 1993213 · Received January 18, 2011

    Report

    Report Number
    2183553-2011-00002
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    November 16, 2010
    Report Date
    January 18, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ANESTHETIZED PATIENT SUSTAINED A 30MM X 30MM BLISTER ON THE ARM, FOLLOWING A MR EXAM. A GE FIELD ENGINEER TESTED THE RF SYSTEM AND THE CALIBRATION OF THE SYSTEM THAT MONITORS RF POWER. THE RF SYSTEM AND RF MONITORING WERE FOUND TO BE WITHIN SPECIFICATIONS. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5T SIGNA HDX ECHOSPEED MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other