BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON LX 1.5T

    MDR report key: 6167570 · Received December 12, 2016

    Report

    Report Number
    2183553-2016-00026
    Event Type
    Malfunction
    Date Received
    December 12, 2016
    Report Date
    February 10, 2017
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K941666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION BY GE HEALTHCARE (GEHC) HAS BEEN COMPLETED. DURING TROUBLESHOOTING, THE GEHC FIELD SERVICE ENGINEER (FSE) SWAPPED THE GRADIENT CABLES AND DID NOT RETURN THEM TO THEIR ORIGINAL POSITION. PREVIOUSLY INSTALLED SPACERS WOULD HAVE PREVENTED THE GRADIENT CABLE SWAP, HOWEVER THIS FEATURE WAS BY-PASSED BY THE GEHC FSE. IN ADDITION, THE GEHC FSE DID NOT PERFORM THE REQUIRED GEOMETRY VERIFICATION PROCEDURE TO CONFIRM THAT THE GRADIENT CABLES WERE CORRECTLY RETURNED TO THEIR ORIGINAL POSITION. GEHC SERVICE DOCUMENTS WERE REVIEWED AND IT WAS CONFIRMED THAT PROPER PROCEDURES ARE IN PLACE. IT WAS DETERMINED THAT THE ROOT CAUSE OF THIS EVENT WAS THAT THE GEHC FSE DID NOT ADHERE TO THE REQUIRED GEHC SERVICE PROCEDURES.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION COULD NOT BE PROVIDED DUE TO COUNTRY PRIVACY LAWS. INCIDENT DATE IS NOT KNOWN AT THIS TIME. UNIQUE IDENTIFIER (UDI) # - UDI LABEL NOT PRESENT. THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AXIAL IMAGES WERE OBSERVED TO BE FLIPPED IN THE LEFT TO RIGHT DIRECTION. GEHC SERVICE IDENTIFIED THAT DURING PRIOR SYSTEM SERVICING/TROUBLESHOOTING, THE GRADIENT CABLES J3 AND J4 OF GRADIENT AMP TERMINAL OF X AXIS HAD BEEN SWAPPED AND NOT RETURNED TO THEIR CORRECT POSITIONS. GEHC SERVICE PLACED THE GRADIENT CABLES TO THEIR CORRECT POSITIONS. NO INJURY OR MISDIAGNOSIS WAS REPORTED DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819051 HORIZON LX 1.5T NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1