FDA Adverse Event
Malfunction
Summary report: N
BIONAIRE
MDR report key: 3820686
·
Received May 2, 2014
Report
- Report Number
- 3003862163-2014-00079
- Event Type
- Malfunction
- Date Received
- May 2, 2014
- Report Date
- May 2, 2014
- Manufacturer
- JARDEN CONSUMER SOLUTIONS, DBA, SUNBEAM PRODUCTS
- Product Code
- KFZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
ABUSE BY THE CONSUMER FROM FAILURE TO TAKE PREVENTATIVE ACTION TO PROPERLY CLEAN THE HUMIDIFIER CAUSED THIS FAILURE.
Description of Event or Problem · 1
CONSUMER ALLEGES HIS HUMIDIFIER BURNED THROUGH THE BOTTOM AND DAMAGED HIS FLOORING. NO INJURIES WERE REPORTED WITH THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 265522 | BIONAIRE | HUMIDIFIER | KFZ | JARDEN CONSUMER SOLUTIONS, DBA, SUNBEAM PRODUCTS | BWM2601 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |