FDA Adverse Event
Malfunction
Summary report: N
NON-REBREATHING OXYGEN MASK
MDR report key: 33207
·
Received May 24, 1996
Report
- Report Number
- MW4001206
- Event Type
- Malfunction
- Date Received
- May 24, 1996
- Report Date
- October 31, 1995
- Manufacturer
- B & F MEDICAL PRODUCTS, INC.
- Product Code
- KGB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ALL MASKS ARE MISSING A ONE-WAY VALVE, WHICH MAKES IT A NON-REBREATHER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NON-REBREATHING OXYGEN MASK | OXYGEN MASK | KGB | B & F MEDICAL PRODUCTS, INC. | 229529 | 64060 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |