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

Model Number HM5082SCS

Device Problems Device Alarm System (1012); Fire (1245); Device Operates Differently Than Expected (2913)

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

Event Date 12/29/2014

Event Type  malfunction  

Event Description

An insurance co is alleging the auto-off feature failed on a humidifier resulting in a fire and causing damage to it's insured's property.

• Brand Name: HOLMES
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): SUNBEAM PROD 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; wichita, KS 67201 ; 3162197325
• MDR Report Key: 4617428
• MDR Text Key: 20724963
• Report Number: 3003862163-2015-00046
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: HM5082SCS
• 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
• Type of Device Usage: Unknown
• Patient Sequence Number: 1