BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICARE FL-9000U HEATER/HUMIDIFIE

    MDR report key: 12909681 · Received December 1, 2021

    Report

    Report Number
    MW5105695
    Event Type
    Injury
    Date Received
    December 1, 2021
    Date of Event
    November 25, 2021
    Report Date
    November 29, 2021
    Manufacturer
    FLEXICARE MEDICAL LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT PLACED ON MAX VENTURI HIGH FLOW DEVICE WITH FLEXICARE FL-9000U HEATER/HUMIDIFIER. NURSING CALLED RT AT HOME BECAUSE HEATER WAS ALARMING "NOT WARMING UP". RT CAME TO HOSPITAL AND ENTERED ROOM. RT CHECKED THE FLUID BAG AND APPLIED PRESSURE TO ASSURE WORKING. TURNED OFF MACHINE, UNPLUGGED IT AND CHANGED OUTLETS. PLUGGED MACHINE AND STARTED AND ASSURED MODE WAS NON-INTUBATED PATIENT. THE MACHINE STOPPED ALARMING AND APPEARED TO BE WORKING. AFTER A FEW SECONDS THE PATIENT POINTED TO THE MACHINE AND THE RT LOOKED AND THE HEATER HAD SMOKE COMING OUT OF IT. RT IMMEDIATELY SHUT OFF THE OXYGEN, REMOVED FROM PATIENT AND PULLED MACHINE TO DOOR. AT THIS POINT THE HEATER WAS IN FLAMES. RT PUT WATER ON IT AND DEPUTY SHERIFF RESPONDED AND NOTICED BURNING FLAME INSIDE THE MACHINE AND MORE WATER PLACED TO EXTINGUISH. HEATER REMOVED FROM POLE AND TAKEN OUTSIDE TO ASSURE EXTINGUISHED. MACHINE WAS THEN PLACED IN SECURE LOCKED ROOM AND LEFT SET UP. ROOM SEALED UNTIL PLANT OPERATIONS ABLE TO INVESTIGATE OUTLETS. ELECTRICAL INSPECTION OF THE ROOM COMPLETED WITH NO PROBLEMS IDENTIFIED. INCIDENT REPORTED TO TRI-ANIM WHERE DEVICE WAS PURCHASED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1809899 FLEXICARE FL-9000U HEATER/HUMIDIFIE HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) BTT FLEXICARE MEDICAL LTD. FLU90000U

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Life Threatening