BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOMAX DSIR

    MDR report key: 3015125 · Received March 16, 2013

    Report

    Report Number
    3015125
    Event Type
    Malfunction
    Date Received
    March 16, 2013
    Date of Event
    January 29, 2013
    Report Date
    March 11, 2013
    Manufacturer
    INO THERAPEUTICS LLC/DBA IKARIA
    Product Code
    MRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO DELIVER NITRIC OXIDE (NO) VIA THE OR VENT CIRCUIT AT 80 PARTS PER MILLION (PPM), THE INOVENT ALARMED FOR LOW NO DELIVERY. I ASSURED THAT THE SETTING WAS CORRECT (SET AT 80PPM) AND TRIED CHANGING TANKS AND REGULATORS WITH SIMILAR RESULTS. AFTER CHANGING OUT THE INOVENT THE NO DELIVERY WORKED CORRECTLY AND THE PATIENT RECEIVED THE APPROPRIATE AMOUNT OF NO. THE FAULTY EQUIPMENT WAS TAGGED AND PULLED FROM USE TO ALLOW FOR INVESTIGATION/REPAIR AS NEEDED.VENTILATOR WAS FOUND TO HAVE A BAD O2 MONITORING BLOCK AS WELL AS A STRAINING SAMPLE PUMP. THIS WAS REPORTED TO IKARIA TECH SUPPORT AND THE DEVICE IS BEING REPLACED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?DELIVERY OF NITROUS OXIDE FOR ANESTHESIA/SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111082 INOMAX DSIR APPARATUS, NITRIC OXIDE DELIVERY MRN INO THERAPEUTICS LLC/DBA IKARIA INOMAX DSIR *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR