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

Model Number SWM5250

Device Problems Melted (1385); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Consumer is claiming that his humidifier emitted smoke and melted on the inside.The were no reports of the injury or property damage with this incident.

• Brand Name: SUNBEAM
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC DBA JARDEN CONSUMER SOLUTIONS; 2381 executive ctr 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; witchita, KS 67201 ; 3162197325
• MDR Report Key: 4368089
• MDR Text Key: 5111386
• Report Number: 3003862163-2014-00157
• 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: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SWM5250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2014
• 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