FDA Adverse Event
Malfunction
Summary report: N
INOVO OXYGEN REGULATOR WITH CHECK VALVE
MDR report key: 239284
·
Received September 10, 1999
Report
- Report Number
- 1062191-1999-00001
- Event Type
- Malfunction
- Date Received
- September 10, 1999
- Date of Event
- September 10, 1999
- Report Date
- September 10, 1999
- Manufacturer
- INOVO, INC.
- Product Code
- CAN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
INOVO'S GENERAL MGR RECEIVED A PHONE CALL FROM A CO THAT THEY HAD A REGULATOR WITH A DISS FITTING THAT HAD A CHECK VALVE UNABLE TO PRODUCE NECESSARY FLOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INOVO OXYGEN REGULATOR WITH CHECK VALVE | OXYGEN REGULATOR | CAN | INOVO, INC. | IN3125R1GREEN | 8/99 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |