BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCOVERY MR750W 3.0T

    MDR report key: 5477455 · Received March 3, 2016

    Report

    Report Number
    2183553-2016-00005
    Event Type
    Malfunction
    Date Received
    March 3, 2016
    Report Date
    June 17, 2016
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K103327
    Removal / Correction Number
    2183553-06/15/16-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    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. PATIENT INFORMATION COULD NOT BE PROVIDED DUE TO COUNTRY PRIVACY LAWS. INCIDENT DATE IS NOT AVAILABLE AT THIS TIME. (B)(6).

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION HAS DETERMINED THAT THE CABLE MODE PRESENT IN THE DESIGN OF THE (B)(4) 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

    THE CUSTOMER REPORTED THAT, DURING A SCAN, THE SCAN STOPPED DUE TO A DRIVER MODULE FAULT. THE CUSTOMER THEN SMELLED SOMETHING BURNING. THE EXAMINATION WAS STOPPED AND THE PATIENT WAS REMOVED FROM THE SYSTEM. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135373 DISCOVERY MR750W 3.0T NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1