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

Model Number HM5305

Device Problems Thermal Decomposition of Device (1071); Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2016

Event Type  malfunction  

Manufacturer Narrative

Consumer has not returned the product.

Event Description

Consumer is alleging that his humidifier overheated and burned a hole in the carpet.There was not a report of injury with this incident.

• Brand Name: HOLMES
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI; 2381 executive center dr.; boca raton FL 33431
• Manufacturer (Section G): DONGGUAN HUIXAN ELECTRICAL PRODUCTS CO.; no. 9112, hung yeh 8th road; tangxia town, dongguan ; CH
• Manufacturer Contact: tracie jones ; p.o. box 2931; wichita, KS 67201 ; 3162197325
• MDR Report Key: 5502922
• MDR Text Key: 40659898
• Report Number: 3003862163-2016-00060
• 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: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HM5305
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1