BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IKARIA

    MDR report key: 1950615 · Received December 28, 2010

    Report

    Report Number
    MW5018760
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 22, 2010
    Report Date
    December 28, 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

    INO DOES FLUCTUATING FROM 13-31 PPM. SET DOSE 20 PPM. THERAPIST CHANGED FILTER AND SAMPLE LINE. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IKARIA INO MAX DS MRN IKARIA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Other