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

Model Number HM5082

Device Problems Break (1069); Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Consumer claims his humidifier caught fire and damaged his flooring.No injuries were reported with this incident.

Manufacturer Narrative

Abuse by the consumer from failure to take preventive action to properly clean the humidifier caused this failure.(b)(4) units of a model with identical heating chamber structure were pulled from warehouse inventory and ran continuously for two months with no incidents observed.No preventive cleaning (planned misuse) was performed during this two month period.Upon tear-down of the units, mineral buildup was observed, but it was not enough to cause the thermostat to open or the tco to activate.

• Brand Name: HOLMES
• Type of Device: HUMIDIFER
• Manufacturer (Section D): SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTIONS; 2381 executive center drive; 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 ; p.o. box 2931; wichita, KS 67201 ; 3162197325
• MDR Report Key: 3568339
• MDR Text Key: 4049256
• Report Number: 3003862163-2014-00001
• 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: 01/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HM5082
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/16/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2010
• 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