BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLMES

    MDR report key: 6186174 · Received December 19, 2016

    Report

    Report Number
    3003862163-2016-00201
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Report Date
    December 29, 2016
    Manufacturer
    SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI
    Product Code
    KFZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER HAS NOT RETURNED UNIT.

    Additional Manufacturer Narrative · 1

    CONSUMER'S FAILURE TO PROPERLY CLEAN/MAINTAIN THE HUMIDIFIER IS A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED AND LED TO THE INCIDENT. THERE IS AN INSTRUCTION THAT STATES, "DO NOT ATTEMPT TO REPAIR OR ADJUST ANY ELECTRICAL OR MECHANICAL FUNCTIONS ON THIS UNIT. DOING SO WILL VOID YOUR WARRANTY. THE INSIDE OF THE UNIT CONTAINS NO USER SERVICEABLE PARTS. ALL SERVICING SHOULD BE PERFORMED BY QUALIFIED PERSONNEL ONLY".

    Description of Event or Problem · 1

    CONSUMER ALLEGES HIS HUMIDIFIER CAUGHT ON FIRE. THERE WAS NO REPORT OF PERSONAL INJURY OR PROPERTY DAMAGE WITH THIS INCIDENT.

    Description of Event or Problem · 1

    CONSUMER ALLEGES HIS HUMIDIFIER CAUGHT ON FIRE. THERE WAS NO REPORT OF PERSONAL INJURY OR PROPERTY DAMAGE WITH THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836352 HOLMES HUMIDIFIER KFZ SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI HM5305

    Patients

    Seq Age Sex Outcome Treatment
    1