BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IKARIA

    MDR report key: 2211450 · Received August 9, 2011

    Report

    Report Number
    MW5021701
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    July 18, 2011
    Report Date
    August 8, 2011
    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

    THE PT WAS INTUBATED AND ON AN INO VENTILATOR WITH CONTINUOUS ALBUTEROL TREATMENTS. A FILTER WAS USED AT ALL TIMES WITH THE SAMPLE LINE FOR THE INO VENT. THE ANALYZED VALUE OF THE INO DELIVERED STARTED TO FLUCTUATE. THE RESPIRATORY THERAPIST CHANGED OUT THE FILTERS AND THE SAMPLE LINE FOR THE ANALYZER, HOWEVER, THE VALUES CONTINUED TO FLUCTUATE PERIODICALLY FROM 7 TO 36 PPM. THE AMOUNT ORDERED WAS 20PPM. A DIFFERENT MACHINE WAS OBTAINED AND PLACED ON THE PT WITHOUT INCIDENT. NO HARM WAS CAUSED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IKARIA INO MAX DS MRN IKARIA DS20090505

    Patients

    Seq Age Sex Outcome Treatment
    1 10 MO Other