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

Model Number SWM6000

Device Problem Smoking (1585)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Consumer alleges his humidifier smoked heavily.There was not a report of personal injury or property damage 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 his humidifier smoked heavily.There was not a report of personal injury or property damage with this incident.

• Brand Name: SUNBEAM
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC.; 2381 executive center dr.; boca raton FL 33431
• MDR Report Key: 11140175
• MDR Text Key: 227083626
• Report Number: 3010341502-2021-00003
• Device Sequence Number: 1
• Product Code: KFZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SWM6000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1