BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOVENT

    MDR report key: 4735618 · Received April 2, 2015

    Report

    Report Number
    4735618
    Event Type
    Malfunction
    Date Received
    April 2, 2015
    Date of Event
    February 24, 2015
    Report Date
    April 2, 2015
    Manufacturer
    INO THERAPEUTICS LLC/DBA IKARIA
    Product Code
    MRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NO READING ON INOVENT MACHINE HIGH, SET AT 40 AND READING LOW 50S AND CLIMBING. NEW INOVENT OBTAINED AND MACHINE CHANGED OUT AND TAGGED WITH A BIOMED SERVICE TAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216260 INOVENT APPARATUS, NITRIC OXIDE MRN INO THERAPEUTICS LLC/DBA IKARIA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *