FDA Adverse Event
Malfunction
Summary report: N
BIONAIRE
MDR report key: 5130897
·
Received September 8, 2015
Report
- Report Number
- 3003862163-2015-00128
- Event Type
- Malfunction
- Date Received
- September 8, 2015
- Date of Event
- August 1, 2015
- Report Date
- September 8, 2015
- Manufacturer
- SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTIONS
- Product Code
- KFZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CONSUMER ALLEGES HER HUMIDIFIER EMITTED SMOKE. THERE WAS NOT A REPORT OF PROPERTY DAMAGE OR INJURY WITH THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 594346 | BIONAIRE | HUMIDIFIER | KFZ | SUNBEAM PRODUCTS, INC., DBA JARDEN CONSUMER SOLUTIONS | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |