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

Model Number HM5305

Device Problems Thermal Decomposition of Device (1071); Smoking (1585)

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

Event Type  malfunction  

Event Description

Consumer claims her humidifier emitted smoke and burned a hole in her carpet.There was not a report of injury with this incident.

Manufacturer Narrative

A prepaid label has been sent to the consumer for return of the product.Consumer has not returned the product.

• Brand Name: HOLMES
• 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; witchita, KS 67201 ; 3162197325
• MDR Report Key: 4613849
• MDR Text Key: 5761258
• Report Number: 3003862163-2015-00044
• 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: 03/09/2015

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: HM5305
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/09/2015
• 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