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

Model Number SWM5250

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Consumer alleges her humidifier caught on fire and caused property damages to her flooring and bedroom.There was not a report of personal injury with this incident.

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 her humidifier caught on fire and caused property damages to her flooring and bedroom.There was not a report of personal injury with this incident.

• Brand Name: SUNBEAM
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC.; 6655 peachtree dunwoody rd.; atlanta GA 30328
• Manufacturer (Section G): DONGGUAN HUIXAN ELECTRICAL PRODUCTS. CO; no. 9112, hung yeh 8th road; tangxia town ; CH
• Manufacturer Contact: michael miles ; 303 nelson ave.; neosho, MO 64850 ; 4174557441
• MDR Report Key: 18545398
• MDR Text Key: 333271179
• Report Number: 3003862163-2024-00008
• 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: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SWM5250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2010
• 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 Sex: Female