BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRDIDIUM 3850

    MDR report key: 3030368 · Received March 27, 2013

    Report

    Report Number
    MW5029546
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 27, 2013
    Manufacturer
    IRADIMED CORP
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MRI IV TUBING AND/OR PUMP FAILED AND PT RECEIVED TOO MUCH MEDICATION (VERSED). PATIENT WAS INTUBATED AND ON VENTILATOR AT THE TIME. NO CHANGES IN VS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126498 MRDIDIUM 3850 PUMP, INFUSION MRI SAFE FRN IRADIMED CORP MRDIUM 3850

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention IV TUBING