MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-17 for BIONAIRE CM2 manufactured by Sunbeam Products, Inc., Dba Jarden Consumer Soluti.
[133485485]
Consumer's insurance agent alleges her client's humidifier smoked and caught fire in the master bedroom causing property damages. There was not a report of personal injury with this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003862163-2019-00007 |
| MDR Report Key | 8256909 |
| Date Received | 2019-01-17 |
| Date of Report | 2019-01-17 |
| 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 | 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 | 0 |
| Brand Name | BIONAIRE |
| Generic Name | HUMIDIFIER |
| Product Code | KFZ |
| Date Received | 2019-01-17 |
| Model Number | CM2 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-17 |