BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMPOWER MR

    MDR report key: 3925148 · Received June 24, 2014

    Report

    Report Number
    3925148
    Event Type
    Death
    Date Received
    June 24, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    IZQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MRI TECHNICIAN JUST FINISHED POWER INJECTING THE PATIENT WITH CONTRAST. THE PATIENT WAS NOT HOLDING HIS BREATH WELL SO SHE WENT INTO THE ROOM TO TALK WITH HIM. HE WAS VISIBLY STRUGGLING TO BREATHE AND WAS BLUE IN COLOR. A CODE WAS CALLED AND THE PATIENT DIED SHORTLY THEREAFTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367935 EMPOWER MR INJECTOR AND SYRINGE, ANGIOGRAPHIC IZQ ACIST MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death CONTRAST INJECTION