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

Model Number HM410-BTUM

Device Problems Thermal Decomposition of Device (1071); Hole In Material (1293)

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

Event Type  malfunction  

Event Description

Consumer claims her humidifier emitted a burning smell.She unplugged it and found a hole had burned into the base of the unit.No injuries were reported with this incident.

Manufacturer Narrative

This product is in the possession of the consumer and has not been examined.A prepaid label has been sent to the consumer for return of the product.

• Brand Name: HOLMES
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): SUNBEAM PRODUCTS INC.; 2381 executive ctr drive; boca ratoan FL
• Manufacturer (Section G): DONGGUAN HUIXAN ELECTRICAL PRODUCTS CO.LTD; no.9-12,hung yeh 8th road; tangxia town,dongguan ; CH
• Manufacturer Contact: tracie jones ; po box 2931; wichita, KS 67201 ; 3162197325
• MDR Report Key: 3648023
• MDR Text Key: 4195320
• Report Number: 3003862163-2014-00008
• 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: Unknown
• Type of Report: Initial
• Report Date: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HM410-BTUM
• 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
• Patient Sequence Number: 1