MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-10-31 for SUNBEAM SWM6000 manufactured by Sunbeam Products, Inc..
[172878717]
There is an instruction that states, "never place humidifier in an area where it is accessible to children" and consumer failed to perform that instruction.
Patient Sequence No: 1, Text Type: N, H10
[172878718]
Consumer alleges humidifier in his child's bedroom smoked heavily and damaged property in the bedroom. There was not a report of personal injury with this incident.
Patient Sequence No: 1, Text Type: D, B5
[180821178]
There is an instruction that states, "never place humidifier in an area where it is accessible to children" and consumer failed to perform that instruction. Consumer's failure to properly clean/maintain the humidifier is a violation of the instructions and warnings provided and led to the incident.
Patient Sequence No: 1, Text Type: N, H10
[180821179]
Consumer alleges humidifier in his child's bedroom smoked heavily and damaged property in the bedroom. There was not a report of personal injury with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003862163-2019-00071 |
| MDR Report Key | 9260508 |
| Report Source | CONSUMER |
| Date Received | 2019-10-31 |
| Date of Report | 2020-02-25 |
| Date of Event | 2019-10-23 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2009-09-14 |
| Date Added to Maude | 2019-10-31 |
| 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 MO 64850 |
| Manufacturer Country | US |
| Manufacturer Postal | 64850 |
| Manufacturer Phone | 4174557441 |
| Manufacturer G1 | DONGGUAN HUIXAN ELECTRICAL PRODUCTS CO. |
| Manufacturer Street | NO. 9112, HUNG YEH 8TH ROAD |
| Manufacturer City | TANGXIA TOWN, |
| Manufacturer Country | CH |
| 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 | 2019-10-31 |
| Returned To Mfg | 2020-02-13 |
| Model Number | SWM6000 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNBEAM PRODUCTS, INC. |
| Manufacturer Address | 2381 EXECUTIVE CENTER DR. BOCA RATON, FL FL 33431 US 33431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-31 |