BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IKARIA

    MDR report key: 1840243 · Received September 14, 2010

    Report

    Report Number
    MW5017479
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 14, 2010
    Manufacturer
    IKARIA
    Product Code
    MRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SCREEN ON INOMAXDS FROZE AND THERAPIST COULD NOT MAKE ANY CHANGES ON THE MACHINE. UNIT HAD TO BE EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IKARIA INOMAXDS MRN IKARIA RENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Required Intervention