BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IKARIA

    MDR report key: 1876137 · Received October 12, 2010

    Report

    Report Number
    MW5017749
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    September 16, 2010
    Report Date
    October 12, 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

    PT IN CARDIAC ARREST. INJECTOR MODULE FAILED ON DS UNIT RESULTING IN DELAY OF CARE. NEW INO DS CALIBRATED AND BROUGHT TO BEDSIDE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Required Intervention