BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MR TWINSPEED

    MDR report key: 1971036 · Received January 6, 2011

    Report

    Report Number
    2183553-2011-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 7, 2010
    Report Date
    January 6, 2011
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K041476
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE REVIEWING THE IMAGES FROM A MRCP (MAGNETIC RESONANCE CHOLANGIOPANCREATOGRAPHY) STUDY ON A GEHC MR SCANNER, IT WAS NOTED THAT THE ORIENTATION OF THE PATIENT'S IMAGE WAS FLIPPED (LIVER WAS ON THE WRONG SIDE OF THE PATIENT'S BODY). NO INJURY OR MISDIAGNOSIS WAS REPORTED. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MR TWINSPEED MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE MEDICAL SYSTEMS, LLC 5110607

    Patients

    Seq Age Sex Outcome Treatment
    1