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 SUNBEAM SWM6000 manufactured by Sunbeam Products, Inc..
[175375068]
There is an instruction that states, "the humidifier should be at least 4" away from the wall for best results". There is an instruction that states, "do not place the humidifier on carpet. The heat sink underneath the humidifier might cause the carpet/wood floor to be discolored and may cause overheating of the unit" and consumer failed to perform that instruction.
Patient Sequence No: 1, Text Type: N, H10
[175375069]
Consumer alleges humidifier caught on fire in his bedroom and damaged his flooring and bed. There was not a report of personal injury with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010341502-2019-00075 |
| MDR Report Key | 9383881 |
| Report Source | CONSUMER |
| Date Received | 2019-11-27 |
| Date of Report | 2019-11-27 |
| Date of Event | 2019-11-22 |
| Date Added to Maude | 2019-11-27 |
| 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, 239000 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 239000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUNBEAM |
| Generic Name | HUMIDIFIER |
| Product Code | KFZ |
| Date Received | 2019-11-27 |
| Model Number | SWM6000 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNBEAM PRODUCTS, INC. |
| Manufacturer Address | 2381 EXECUTIVE CENTER DR. BOCA RATON FL 33431 US 33431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-27 |