BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0 T DISCOVERY MR 750

    MDR report key: 1709031 · Received June 1, 2010

    Report

    Report Number
    2183553-2010-00017
    Event Type
    Malfunction
    Date Received
    June 1, 2010
    Date of Event
    March 11, 2010
    Report Date
    March 11, 2010
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K081028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY EVAL ON 05/03/2010 REVEALED THAT THE FAILURE MODE THAT RESULTED IN THE SHADING ARTIFACT WAS SIMILAR TO THE ISSUE REPORTED FOR MDR# 2183553-2010-00012. GE HEALTHCARE HAS INITIATED AN INVESTIGATION AND IS STILL ONGOING.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER SITE THAT IMAGES OBTAINED FROM A BREAST EXAM SHOWED SHADING ARTIFACTS. ADD'L EVAL BY GE ENGINEERING REVEALED THAT THE ARTIFACTS RESULTED FROM A CRACKED CAPACITOR ON THE BODY COIL BOARD. THE DAMAGED CAPACITOR CAN BE POTENTIALLY CAUSED BY ARCING. FAILED CAPACITOR AND ARCING CAN RESULT IN THE HEATING OF THE BORE WALL. WHILE THE ARTIFACT ITSELF IS NOT LIKELY TO RESULT IN MISDIAGNOSIS OR SERIOUS INJURY DUE TO ITS OBVIOUS NATURE, THERE IS A CONCERN FOR POSSIBLE BURN IF A PT WAS TO COME IN CONTACT WITH THE HEATER BORE WALL. NO INJURY OR MISDIAGNOSIS WAS REPORTED RELATING TO THE ARTIFACT. LIKEWISE, NO INJURY WAS REPORTED DUE TO A POTENTIALLY HEATED BORE WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.0 T DISCOVERY MR 750 LNH GE MEDICAL SYSTEMS, LLC 5159730

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK