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

Model Number SWM6000-BWM

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

There is an instruction that states, "never place humidifier in an area where it is accessible to children" and consumer failed to perform that instruction.There is an instruction that states, "never use humidifier in a closed room, particularly where a child may be sleeping, resting, or playing" and consumer failed to perform that instruction.Consumer has not returned.

Event Description

Consumer alleges through (b)(6) that her warm mist humidifier was pulled down by and caused burns to her twin daughters.There was not a report of property damages with this incident.

• Brand Name: SUNBEAM
• 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: michael miles ; 303 nelson ave.; neosho, MO 64850 ; 4174557441
• MDR Report Key: 6200018
• MDR Text Key: 63195338
• Report Number: 3003862163-2016-00206
• 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: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: SWM6000-BWM
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other