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

Model Number HM5250

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Consumer alleges his humidifier emitted smoke.No injuries or property damages were reported with this incident.

Manufacturer Narrative

Consumer was sent a prepaid label to return the product for evaluation, but the consumer has not returned the product.

• Brand Name: HOLMES
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): JARDEN CONSUMER SOLUTIONS, DBA, SUNBEAM PRODUCTS; 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: 3776107
• MDR Text Key: 18793263
• Report Number: 3003862163-2014-00048
• 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: 03/18/2014

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: HM5250
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/19/2014
• 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