BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INO MAX DSR

    MDR report key: 5083648 · Received September 17, 2015

    Report

    Report Number
    5083648
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Date of Event
    July 27, 2015
    Report Date
    September 8, 2015
    Manufacturer
    INO THERAPEUTICS LLC/DBA IKARIA
    Product Code
    MRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON ENTERING ROOM INO SCREEN DISPLAYED "CHANGE SAMPLE LINE". SAMPLE LINE CHANGED AND SCREEN CONTINUED TO DISPLAY ON MONITOR CHANGE SAMPLE LINE. INO MACHINE CHANGED TO A NEW ONE. PATIENT REMAINED STABLE THROUGHOUT THE CHANGING OF INO MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616092 INO MAX DSR APPARATUS, NITRIC OXIDE DELIVERY MRN INO THERAPEUTICS LLC/DBA IKARIA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR