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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SUNBEAM PRODUCTS, INC. SUNBEAM; HUMIDIFIER

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SUNBEAM PRODUCTS, INC. SUNBEAM; HUMIDIFIER Back to Search Results
Model Number SUL495
Device Problem Smoking (1585)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Consumer claims her humidifier emitted smoke.There were no reports of injury or property damage with this incident.
 
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Brand Name
SUNBEAM
Type of Device
HUMIDIFIER
Manufacturer (Section D)
SUNBEAM PRODUCTS, INC.
2381 executive center dr.
dba jarden consumer solutions
boca raton FL
Manufacturer (Section G)
DONGGUAN HUIXAN ELECTRICAL PRODUCTS CO.LTD
no.9-12,hung yeh 8th road
tangxia town,dongguan
CH  
Manufacturer Contact
tracie jones
p.o. box 2391
wichita, KS 67201
3162197325
MDR Report Key4307982
MDR Text Key18087123
Report Number3003862163-2014-00142
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 11/20/2014
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 NumberSUL495
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/20/2014
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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