BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCOVERY MR750W 3.0T

    MDR report key: 5348608 · Received January 6, 2016

    Report

    Report Number
    2183553-2016-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2016
    Date of Event
    October 23, 2015
    Report Date
    June 17, 2016
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K130115
    Removal / Correction Number
    2183553-06/15/16-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE PATIENT INFORMATION WAS RECEIVED FROM THE CUSTOMER. GE HEALTHCARE'S INVESTIGATION HAS DETERMINED THAT THE CABLE MODE PRESENT IN THE DESIGN OF THE MR750W RF BODY COIL IS THE ROOT CAUSE OF ARCING THAT HAS LED TO EXCESS HEAT/DISCOLORATION OF THE SURFACE OF THE PATIENT BORE. GE HEALTHCARE IS INITIATING AN ACTION IN THE FIELD TO INSPECT UNITS TO DETERMINE WHICH UNITS HAVE THE POTENTIAL CABLE MODE, AND MAKE ANY CORRECTIONS IF NECESSARY. THIS ACTION WAS REPORTED TO THE FDA UNDER CORRECTION NUMBER 2183553-06/15/16-001-C ON JUNE 15, 2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CUSTOMER CALLED FOR SERVICE DUE TO A SMELL. THERE WAS DISCOLORATION FOUND IN THE BORE. NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8172 DISCOVERY MR750W 3.0T SYSTEM, NUCLEAR MAGNETIC RESONANCE LNH GE MEDICAL SYSTEMS, LLC MDF020

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR