BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.0T SIGNA MR 750

    MDR report key: 1709033 · Received June 1, 2010

    Report

    Report Number
    2183553-2010-00016
    Event Type
    Malfunction
    Date Received
    June 1, 2010
    Date of Event
    April 24, 2009
    Report Date
    April 24, 2009
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K081028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRELIMINARY EVAL ON (B)(4) 2010 REVEALED THAT THE FAILURE MODE THAT RESULTED TO THE DD ERROR 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 THAT AN ERROR OCCURRED DURING A DIAGNOSTIC DISABLE (DD) DIAGNOSTICS OF THE MR SYSTEM, INDICATING A COIL FAILURE. EVAL OF THE COIL FAILURE REVEALED THE DD ERROR WAS GENERATED BECAUSE OF AN ARCING ON THE BODY COIL BOARD, WHICH IN TURN WAS CAUSED BY A CAPACITOR FAILURE. FAILED CAPACITOR AND ARCING CAN RESULT IN THE HEATING OF THE BORE WALL. THE CONCERN IS FOR A POSSIBLE BURN IF THE PT WAS TO COME IN CONTACT WITH THE HEATED BORE WALL. THERE WAS NO PT INVOLVEMENT OR ANY INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.0T SIGNA MR 750 LNH GE MEDICAL SYSTEMS, LLC 5148810-2

    Patients

    Seq Age Sex Outcome Treatment
    1