BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5T HDX

    MDR report key: 1959255 · Received December 16, 2010

    Report

    Report Number
    2183553-2010-00049
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    June 7, 2010
    Report Date
    December 16, 2010
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REVIEW OF GE HEALTHCARE SERVICE RECORDS SHOWS THAT THE BRM RF COIL OF THIS GE HEALTHCARE MR SYSTEM WAS REPLACED AND RETURNED TO THE MANUFACTURING SITE FOR REPAIR. INITIAL EVALUATION REVEALED THAT THE BRM RF COIL MAY HAVE BEEN SUBJECT TO A THERMAL EVENT. NO INJURY WAS REPORTED. 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 HDX LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1