BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLMES

    MDR report key: 3072313 · Received April 5, 2013

    Report

    Report Number
    3003862163-2013-00053
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Report Date
    April 4, 2013
    Manufacturer
    JARDEN CONSUMER SOLUTIONS, DBA, SUNBEAM PRODUCTS
    Product Code
    KFZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ABUSE BY THE CONSUMER FROM FAILURE TO TAKE PREVENTIVE ACTION TO PROPERLY CLEAN THE HUMIDIFIER CAUSED THIS FAILURE. SUMMARY: THE HEATING ELEMENT MELTED AT THE BOTTOM OF THE UNIT. THERE APPEARS TO BE A LAYER OF HEAVY MINERAL BUILD-UP ON THE HEATING ELEMENT AND THE HEATING CHAMBER, WHICH INDICATES THE CONSUMER DID NOT PROPERLY CLEAN THE UNIT, WHICH IS AN ABUSE OF THE PRODUCT. MOISTURE ENTERED THE UNIT AND PROVIDED AN ELECTRICAL PATH THAT BY-PASSED THE THERMOSTAT AND TCO NOT ALLOWING THE HEATER TO SHUT DOWN.

    Description of Event or Problem · 1

    CONSUMER ALLEGES HIS HUMIDIFIER STARTED TO MAKE NOISE AND EMIT SMOKE. NO INJURIES OR PROPERLY DAMAGES WERE REPORTED WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140308 HOLMES HUMIDIFIER KFZ JARDEN CONSUMER SOLUTIONS, DBA, SUNBEAM PRODUCTS HM5250 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1