BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR

    MDR report key: 5273269 · Received December 8, 2015

    Report

    Report Number
    5273269
    Event Type
    Malfunction
    Date Received
    December 8, 2015
    Date of Event
    September 24, 2014
    Report Date
    November 11, 2015
    Manufacturer
    INO THERAPEUTICS LLC/DBA IKARIA
    Product Code
    MRN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S CONDITION WARRANTED THE USE OF NITRIC OXIDE. WHEN INO WAS PLACED IN LINE, A "SERVICE FAILURE" WARNING APPEARED AND THE EQUIPMENT DID NOT FUNCTION. THE VENTILATOR CIRCUIT WAS BROKEN TO AGAIN TO TAKE INO OUT OF LINE WHILE A SECOND INO MACHINE WAS OBTAINED. THIS DELAYED PATIENT CARE BY SEVERAL MINUTES ON A CRITICALLY ILL PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806411 INOMAX DSIR APPARATUS, NITRIC OXIDE DELIVERY MRN INO THERAPEUTICS LLC/DBA IKARIA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR