SUNBEAM SWM6000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-17 for SUNBEAM SWM6000 manufactured by Sunbeam Products, Inc., Dba Jarden Consumer Soluti.

Event Text Entries

[133838777] An insurance company is making a subrogation claim under case reference (b)(4) and alleging that a humidifier was the cause of a fire that damaged its insured's property. There was not a report of personal injury with this incident.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3010341502-2019-00006
• MDR Report Key: 8256904
• Date Received: 2019-01-17
• Date of Report: 2019-01-17
• Date of Event: 2017-11-29
• Date Added to Maude: 2019-01-17
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MICHAEL MILES
• Manufacturer Street: 303 NELSON AVE.
• Manufacturer City: NEOSHO MO 64850
• Manufacturer Country: US
• Manufacturer Postal: 64850
• Manufacturer Phone: 4174557441
• Manufacturer G1: CHUZHOU DONLIM ELECTRICAL APPLIANCES CO.,LTD.
• Manufacturer Street: NO.1777 YANGZI EAST ROAD
• Manufacturer City: CHUZHOU, ANHUI 239000
• Manufacturer Country: CH
• Manufacturer Postal Code: 239000
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: SUNBEAM
• Generic Name: HUMIDIFIER
• Product Code: KFZ
• Date Received: 2019-01-17
• Model Number: SWM6000
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTI
• Manufacturer Address: 2381 EXECUTIVE CENTER DR. BOCA RATON FL 33431 US 33431

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-01-17