MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-17 for SUNBEAM SWM2410 manufactured by Sunbeam Products, Inc., Dba Jarden Consumer Soluti.
[133485857]
Consumer's father alleges his (b)(6) year old son was using the humidifier in his room and it filled his room with smoke then caught on fire damaging the dresser it was sitting on and carpeting. There was a report of a minor injury to his son's arm while extinguishing the unit.
Patient Sequence No: 1, Text Type: D, B5
[140027112]
Consumer's failure to properly clean/maintain the humidifier is a violation of the instructions and warnings provided and led to the incident. Establishment registration #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[140027113]
Consumer's father alleges his (b)(6) son was using the humidifier in his room and it filled his room with smoke then caught on fire damaging the dresser it was sitting on and carpeting. There was a report of a minor injury to his son's arm while extinguishing the unit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010341502-2019-00008 |
| MDR Report Key | 8256921 |
| Date Received | 2019-01-17 |
| Date of Report | 2019-03-18 |
| Device Manufacturer Date | 2009-10-15 |
| 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 |
| Brand Name | SUNBEAM |
| Generic Name | HUMIDIFIER |
| Product Code | KFZ |
| Date Received | 2019-01-17 |
| Model Number | SWM2410 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-17 |