BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE HEALTHCARE OPTIMA MR 450W SYSTEM

    MDR report key: 2975406 · Received February 7, 2013

    Report

    Report Number
    2183553-2013-00005
    Event Type
    Malfunction
    Date Received
    February 7, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 9, 2013
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K091536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    A GE FIELD ENGINEER WAS DISPATCHED TO A CUSTOMER SITE WHERE IT WAS DETERMINED THAT THE RF BODY COIL REQUIRED REPLACEMENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. THE COIL WAS RETURNED TO THE MANUFACTURING SITE FOR FURTHER INVESTIGATION, WHERE IT WAS REVEALED THAT THE PRINTED CIRCUIT BOARD WITHIN THE BODY COIL WAS BURNED. THE CIRCUIT BOARD MANUFACTURER WAS CONTACTED TO PERFORM FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53334 GE HEALTHCARE OPTIMA MR 450W SYSTEM MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC 5373011

    Patients

    Seq Age Sex Outcome Treatment
    1 RF BODY COIL