SUNBEAM SWM6000CN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-30 for SUNBEAM SWM6000CN manufactured by Sunbeam Products, Inc..

Event Text Entries

[146660025] Consumer discarded unit.
Patient Sequence No: 1, Text Type: N, H10


[146660028] Consumer alleges her humidifier caught on fire and smoked. There was not a report of personal injury or property damages with this incident.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010341502-2019-00044
MDR Report Key8654121
Date Received2019-05-30
Date of Report2019-05-30
Date Added to Maude2019-05-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMICHAEL MILES
Manufacturer Street303 NELSON AVE.
Manufacturer CityNEOSHO MO 64850
Manufacturer CountryUS
Manufacturer Postal64850
Manufacturer Phone4174557441
Manufacturer G1CHUZHOU DONLIM ELECTRICAL APPLIANCES CO.,LTD.
Manufacturer StreetNO.1777 YANGZI EAST ROAD
Manufacturer CityCHUZHOU, 239000
Manufacturer CountryCH
Manufacturer Postal Code239000
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSUNBEAM
Generic NameHUMIDIFIER
Product CodeKFZ
Date Received2019-05-30
Model NumberSWM6000CN
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSUNBEAM PRODUCTS, INC.
Manufacturer Address2381 EXECUTIVE CENTER DR. BOCA RATON FL 33431 US 33431


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-30

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