BEUDAMED
    FDA Adverse Event Death Summary report: N

    1.5T SIGNA ECHOSPEED HD

    MDR report key: 920424 · Received October 1, 2007

    Report

    Report Number
    2183553-2007-00028
    Event Type
    Death
    Date Received
    October 1, 2007
    Date of Event
    September 5, 2007
    Report Date
    September 5, 2007
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K041476
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A GE FIELD ENGINEER EVALUATED THE SYSTEM AND IT IS OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPIRED DURING AN MR SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5T SIGNA ECHOSPEED HD LNH GE MEDICAL SYSTEMS, LLC 2317112-6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death