MAUDE Adverse Event Report: SUNBEAM PRODUCTS INC HOLMES; HUMIDIFER

Model Number HM410

Device Problems Thermal Decomposition of Device (1071); Hole In Material (1293); Device Emits Odor (1425)

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

Event Type  malfunction  

Event Description

Consumer claims her humidifier emitted a burning smell and she discovered a hole had burned through the bottom 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 will be sent to the consumer for return of the product.

• Brand Name: HOLMES
• Type of Device: HUMIDIFER
• 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.LTD; no.9112,hung yeh 8th road; tangxia town,dongguan ; CH
• Manufacturer Contact: tracie jones ; po box 2931; wichita, KS 67201 ; 3162197325
• MDR Report Key: 3944469
• MDR Text Key: 16176608
• Report Number: 3003862163-2014-00084
• 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: 05/08/2014

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: HM410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2014
• 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