BIONAIRE BWM2601

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-11-27 for BIONAIRE BWM2601 manufactured by Sunbeam Products, Inc..

Event Text Entries

[175373916] Consumer alleges his humidifier caught on fire. There was not a report of property damage or personal injury with this incident.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003862163-2019-00076
MDR Report Key9383946
Report SourceCONSUMER
Date Received2019-11-27
Date of Report2019-11-27
Date Added to Maude2019-11-27
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 G1DONGGUAN HUIXAN ELECTRICAL PRODUCTS CO.
Manufacturer StreetNO. 9112, HUNG YEH 8TH ROAD
Manufacturer CityTANGXIA TOWN,
Manufacturer CountryCH
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIONAIRE
Generic NameHUMIDIFIER
Product CodeKFZ
Date Received2019-11-27
Model NumberBWM2601
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 2019-11-27

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