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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI SUNBEAM; HUMIDIFIER
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SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI SUNBEAM; HUMIDIFIER Back to Search Results
Model Number SWM5250
Device Problems Thermal Decomposition of Device (1071); Smoking (1585)
Patient Problem No Code Available (3191)
Event Date 11/25/2015
Event Type  malfunction  
Manufacturer Narrative
Consumer's failure to properly clean/maintain the humidifier is a violation of the instructions and warnings provided and led to the incident.
 
Event Description
Consumer alleges that his humidifier emitted smoke, smoldered and burned the heating element.He also alleges this incident caused his daughter to develop a bad cough.
 
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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
tracie jones
p.o. box 2931
wichita, KS 67201
3162197325
MDR Report Key5344907
MDR Text Key35426921
Report Number3003862163-2016-00002
Device Sequence Number1
Product Code KFZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 01/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberSWM5250
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2015
Date Manufacturer Received12/23/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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