MAUDE Adverse Event Report: SUNBEAM PRODUCTS, INC. HOLMES; HUMIDIFIER

Model Number HWM6000

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

Consumer alleges his humidifier caught on fire while moving the unit to a sink he received burns to one of his hands and property damage to an area rug from the melted plastic.

Manufacturer Narrative

Consumer's failure to properly clean/maintain the humidifier is a violation of the instructions and warnings provided and led to the incident.

Event Description

Consumer alleges his humidifier caught on fire while moving the unit to a sink he received burns to one of his hands and property damage to an area rug from the melted plastic.

• Brand Name: HOLMES
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC.; 6655 peachtree dunwoody rd.; atlanta GA 30328
• Manufacturer (Section G): CHUZHOU DONLIM ELECTRICAL APPLIANCES CO.,LTD.; no. 1777 yangzi east road; chuzhou, anhui 23900 0; CH 239000
• Manufacturer Contact: michael miles ; 303 nelson ave.; neosho, MO 64850 ; 4174557441
• MDR Report Key: 18668262
• MDR Text Key: 334904047
• Report Number: 3010341502-2024-00010
• Device Sequence Number: 1
• Product Code: KFZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HWM6000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male