MAUDE Adverse Event Report: KAZ USA, A HELEN OF TROY COMPANY HCM - 300T ULTRAVIOLET GERM-FREE COOL MIST HUMIDIFIER

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2017

Event Type  No Answer Provided  

Event Description

Humidifier was being used in a bedroom.It had remained plugged in and when i walked into the room, i could smell a plastic burning smell.I investigated and found the humidifier smoking.I immediately pulled the power cord out of the device then removed the plug from the wall.Upon removing the cord from the device i observed as it was red hot.The device sustained scorching in the form of brown around the power inlet.Device was very close to starting a fire.Document number: (b)(4).Report number: (b)(4).The product was not damaged before the incident.The product was not modified before the incident.

• Brand Name: HCM - 300T ULTRAVIOLET GERM-FREE COOL MIST HUMIDIFIER
• Type of Device: HCM - 300T ULTRAVIOLET GERM-FREE COOL MIST HUMIDIFIER
• Manufacturer (Section D): KAZ USA, A HELEN OF TROY COMPANY
• MDR Report Key: 7147533
• MDR Text Key: 95929478
• Report Number: MW5074225
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1