BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HONEYWELL TOP FILL WARM MIST HUMIDIFIER MODEL HWM-340 SERIES

    MDR report key: 5409629 · Received February 2, 2016

    Report

    Report Number
    MW5059993
    Event Type
    Injury
    Date Received
    February 2, 2016
    Date of Event
    January 1, 2016
    Report Date
    January 1, 2016
    Manufacturer
    KAZ, USA
    Product Code
    KFZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I BOUGHT A BRAND NEW HONEYWELL TOP FILL WARM MIST HUMIDIFIER MODEL HWM-340, MANUFACTURED BY KAZ USA. MY (B)(6) BABY IS SICK AND NEEDED MORE HUMID AIR. I FILLED IT WITH WATER, PER THE INSTRUCTION BOOKLET AND TURNED IT ON. AFTER ABOUT 30 MINUTES, I NOTICED A SMOKE LINGERING AROUND THE UNIT AND IN THE AIR, AND THERE WAS A STRONG SMELL OF MELTED PLASTIC. I IMMEDIATELY PULLED THE PLUG. THE SIDE OF THE UNIT WAS EXTRAORDINARILY HOT. I HAD TO FIND A SAFE PLACE FOR MY BABY, WHO WAS ALREADY HAVING PROBLEMS BREATHING, WHILE I VENTILATED MY HOSE BECAUSE OF THE STRONG SMELL. DOCUMENT NUMBER: (B)(4). RETAILER: (B)(6). RETAILER STATE: (B)(6). PURCHASED DATE 12/31/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63691 HONEYWELL TOP FILL WARM MIST HUMIDIFIER MODEL HWM-340 SERIES NURSERY EQUIPMENT AND SUPPLIES KFZ KAZ, USA HWM340BTD1

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO