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

Model Number SWM6000

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2019

Event Type  malfunction  

Manufacturer Narrative

There is an instruction that states, "never place humidifier in an area where it is accessible to children" and consumer failed to perform that instruction.

Event Description

Consumer alleges humidifier in his child's bedroom smoked heavily and damaged property in the bedroom.There was not a report of personal injury with this incident.

Manufacturer Narrative

There is an instruction that states, "never place humidifier in an area where it is accessible to children" and consumer failed to perform that instruction.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 humidifier in his child's bedroom smoked heavily and damaged property in the 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.; 2381 executive center dr.; boca raton, fl FL 33431
• 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, MO 64850 ; 4174557441
• MDR Report Key: 9260508
• MDR Text Key: 172878717
• Report Number: 3003862163-2019-00071
• 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: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SWM6000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2009
• 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