BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIUM 3850

    MDR report key: 2211489 · Received August 9, 2011

    Report

    Report Number
    MW5021710
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    May 2, 2011
    Report Date
    August 9, 2011
    Manufacturer
    IRADIMED CORP
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MRI COMPATIBLE IV PUMP OVERINFUSED DIPRIVAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRIDIUM 3850 MRI IV PUMP FRN IRADIMED CORP 3850

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other