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

Model Number BWM5905

Device Problems Break (1069); Melted (1385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Consumer alleges her humidifier melted and caused smoke damage.There was not a report of injury with this incident.

Manufacturer Narrative

A prepaid label has been sent to the retailer for return of the prod.Retailer has not returned to prod.

• Brand Name: BIONAIRE
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): SUNBEAM PRODUCTS INC, DBA JARDEN CONSUMER SOLUTIONS; 2381 executive center dr; boca raton FL
• Manufacturer (Section G): DONGGUAN HUIXAN ELECTRICAL PRODUCTS CO; no.9112,hung yeh 8th road; tangxia town,dongguan ; CH
• Manufacturer Contact: tracie jones ; po box 2931; wichita, KS 67201 ; 3162197325
• MDR Report Key: 4714144
• MDR Text Key: 19352886
• Report Number: 3003862163-2015-00069
• 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
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: BWM5905
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• 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