BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY

    MDR report key: 7374792 · Received March 27, 2018

    Report

    Report Number
    2183553-2018-00005
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    March 2, 2018
    Report Date
    June 21, 2018
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K013636
    Removal / Correction Number
    2183553-06/13/18-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. 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

    GE HEALTHCARE'S INVESTIGATION HAS DETERMINED THAT THE INCIDENT OCCURRED DUE TO THE LATEST ON-SITE SOFTWARE VERSION NOT BEING REINSTALLED AFTER SERVICE ACTIVITIES WERE PERFORMED THAT REQUIRED SOFTWARE TO BE RELOADED. UNDER SPECIFIC CONDITIONS, THIS SOFTWARE CONFIGURATION RESULTED IN AN IMAGE FLIP LEFT/RIGHT. GE HEALTHCARE IS INITIATING AN ACTION IN THE FIELD AS REPORTED TO THE FDA UNDER CORRECTION NUMBER 2183553-06/13/18-001-C ON JUNE 13, 2018.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: GE HEALTHCARE'S INVESTIGATION HAS DETERMINED THAT THE INCIDENT OCCURRED DUE TO THE LATEST ON-SITE SOFTWARE VERSION NOT BEING REINSTALLED AFTER SERVICE ACTIVITIES WERE PERFORMED THAT REQUIRED SOFTWARE TO BE RELOADED. UNDER SPECIFIC CONDITIONS, THIS SOFTWARE CONFIGURATION RESULTED IN AN IMAGE FLIP LEFT/RIGHT. GE HEALTHCARE IS INITIATING AN ACTION IN THE FIELD AS REPORTED TO THE FDA UNDER CORRECTION NUMBER 2183553-06/13/18-003-C ON JUNE 13, 2018. CORRECTION/REMOVAL REPORT NUMBER: 2183553-06/13/18-003-C

    Description of Event or Problem · 1

    IT WAS REPORTED TO GE HEALTHCARE THAT AXIAL T1 IMAGES OF A BRAIN MRI EXAM DEMONSTRATED A RIGHT TO LEFT IMAGE FLIP, RESULTING IN INCORRECTLY DISPLAYED ANATOMY. THE PATIENT HAD A KNOWN LEFT SIDE BRAIN TUMOR, WHICH MADE THE ISSUE DETECTABLE TO THE USER. NO INJURY OR MISDIAGNOSIS OCCURRED DUE TO THIS ISSUE. AN INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216191 SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1