MAUDE Adverse Event Report: SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI BIONAIRE; HUMIDIFIER

Model Number BWM2600

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Consumer alleges his humidifier filled his room with smoke and damaged his flooring.There was not a report of personal injury with this incident.

Event Description

Consumer alleges his humidifier filled his room with smoke and damaged his flooring.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.

• Brand Name: BIONAIRE
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI; 2381 executive center dr.; boca raton FL 33431
• MDR Report Key: 7274294
• MDR Text Key: 100517888
• Report Number: 3003862163-2018-00036
• 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: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: BWM2600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2018
• Supplement Dates Manufacturer Received: 03/01/2018
• Supplement Dates FDA Received: 03/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1