FDA Adverse Event
Malfunction
Summary report: N
BIONAIRE
MDR report key: 3850953
·
Received March 24, 2014
Report
- Report Number
- 3006534621-2014-00052
- Event Type
- Malfunction
- Date Received
- March 24, 2014
- Report Date
- March 22, 2014
- Manufacturer
- SUNBEAM PRODUCTS, INC; DBA JARDEN CONSUMER SOLUTIONS
- Product Code
- KFZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A PREPAID LABEL HAS BEEN SENT TO THE CONSUMER FOR RETURN OF THE PRODUCT. CONSUMER HAS NOT RETURNED THE PRODUCT.
Description of Event or Problem · 1
CONSUMER CLAIMS HER HUMIDIFIER CAUGHT ON FIRE. THERE WERE NO REPORTS OF INJURIES OR PROPERTY DAMAGES WITH THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172723 | BIONAIRE | HUMIDIFIER | KFZ | SUNBEAM PRODUCTS, INC; DBA JARDEN CONSUMER SOLUTIONS | CP2550 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |