BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOMAX DSIR

    MDR report key: 11378603 · Received February 25, 2021

    Report

    Report Number
    11378603
    Event Type
    Death
    Date Received
    February 25, 2021
    Date of Event
    January 25, 2021
    Report Date
    January 28, 2021
    Manufacturer
    MALLINCKRODT MANUFACTURING LLC
    Product Code
    MRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CALLED TO PATIENT BEDSIDE AT 0930. DR WAS BEDSIDE. VENT FIO2 ON 100%. SPO2 IN 70S. PATIENT WAS TAKEN OFF VENTILATOR AND BAGGED WITH INO FLOWMETER AND AMBU BAG. PATIENT BAGGED FOR 15-20 MINUTES. SPO2 IN MID TO LOW 80S. INSTRUCTED TO PLACE PATIENT BACK ON VENTILATOR. PEEP INCREASED TO 10 CM H2O. HEART RATE STARTED TO DECREASE. I REPOSITIONED MYSELF TO THE HEAD OF THE BED INSTEAD OF THE LEFT SIDE OF PATIENT. SPO2 IN 80S. PATIENT TAKEN OFF VENTILATOR AGAIN AND BAGGED. AMBU BAG USED AGAIN THAT WAS ATTACHED TO INO VENTILATOR. UNABLE TO TURN FLOW ON INO VENT. CALLED RRT TO BEDSIDE TO HELP TROUBLE SHOOT INO VENTILATOR FLOWMETER. SPO2 DECREASED TO 0. AMBU BAG DISCONNECTED FROM INO VENT FLOWMETER AND ATTACHED TO REGULAR O2 FLOW METER. PATIENT NOW OFF INO VENTILATOR AND USING O2 ONLY. SPO2 INCREASED TO 80S. PROVIDER AT BEDSIDE TO TROUBLE SHOOT INO VENTILATOR, INO FLOWMETER DID NOT WORK FOR HIM EITHER. HE ALSO BROUGHT A NEW INO VENTILATOR WITH HIM. HE PUT PATIENT ON NEW INO VENTILATOR. BAGGED WITH NEW INO VENTILATOR FLOWMETER. SPO2 STAYED IN THE 80S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279178 INOMAX DSIR APPARATUS, NITRIC OXIDE DELIVERY MRN MALLINCKRODT MANUFACTURING LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 29565 DA Death