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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 SWM6000
Device Problems Thermal Decomposition of Device (1071); Melted (1385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Consumer alleges her humidifier melted and burned from the bottom of the unit.There was not a report of personal injury or property damage with this incident.
 
Event Description
Consumer alleges her humidifier melted and burned from the bottom of the unit.There was not a report of personal injury or property damage with this incident.
 
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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)
CHUZHOU DONLIM ELECTRICAL APPLIANCES CO.,LTD.
no.1777 yangzi east road
chuzhou, anhui 23900 0
CH   239000
Manufacturer Contact
michael miles
303 nelson ave.
neosho, MO 64850
4174557441
MDR Report Key7038407
MDR Text Key93221785
Report Number3010341502-2017-00176
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,Followup
Report Date 11/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberSWM6000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2015
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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