BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HONEYWELL

    MDR report key: 10279775 · Received July 15, 2020

    Report

    Report Number
    1314800-2020-00030
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    June 5, 2020
    Report Date
    July 13, 2020
    Product Code
    KFZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING, BUT IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT SHE HAD A LEAKING HUMIDIFIER WHICH SHE CONTINUED TO USE. SHE REPORTED THAT THE DEVICE BEGAN LEAKING AGAIN, AND WHEN SHE WENT TO UNPLUG THE UNIT SHE RECEIVED AN ELECTRICAL SHOCK WHICH REQUIRED MEDICAL INTERVENTION. THE INSTRUCTIONS FOR PROPER USE HAVE CLEAR WARNINGS WHICH STATE, "CAUTION: USE CARE WHEN HANDLING WATER TANK TO AVOID UNNECESSARY IMPACT. BANGING OR DROPPING THE WATER TANK COULD RESULT IN DAMAGE TO THE TANK THAT MAY CAUSE LEAKING", AS WELL AS, "CAUTION: TO AVOID ELECTRIC SHOCK, DO NOT PLUG HUMIDIFIER INTO OUTLET WITH WET HANDS. SHUT OFF AND UNPLUG HUMIDIFIER BEFORE MOVING." KAZ USA, INC. HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740633 HONEYWELL COOL MOISTURE HUMIDIFIER KFZ HEV615B UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R