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U.S. Department of Health and Human Services

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

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SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTIONS HOLMES; HUMIDIFER Back to Search Results
Model Number HM5250
Device Problems Thermal Decomposition of Device (1071); Smoking (1585)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Consumer alleges her humidifier emitted smoke and burned, resulting g in damage to her dresser.There were no injuries reported with this incident.
 
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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 Key4321848
MDR Text Key5245656
Report Number3003862163-2014-00145
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 Other
Reporter Occupation Other
Type of Report Initial
Report Date 11/26/2014
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 NumberHM5250
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/26/2014
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 Number1
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