FDA Adverse Event
Malfunction
Summary report: N
INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR
MDR report key: 19730903
·
Received July 12, 2024
Report
- Report Number
- 3004672275-2024-00014
- Event Type
- Malfunction
- Date Received
- July 12, 2024
- Date of Event
- March 1, 2024
- Report Date
- July 12, 2024
- Manufacturer
- INOGEN, INC
- Product Code
- CAW
- UDI-DI
- 00817131020063
- PMA / PMN Number
- K032818
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
A RETURN OF THE DEVICE HAS BEEN INITIATED. ONCE THE DEVICE IS RECEIVED AN INVESTIGATION WILL BE CONDUCTED AND A FOLLOWUP WILL BE SUBMITTED IF REQUIRED.
Description of Event or Problem · 0
THE INOGEN G3 PORTABLE OXYGEN CONCENTRATOR DID NOT PRODUCE OXYGEN WITHOUT ANY WARNING. PATIENT IS IN THE EMERGENCY ROOM AND CLAIMS IT IS A RESULT OF POC AND GS NOT PROVIDING O2.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272382 | INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR | INOGEN ONE G3 PORTABLE OXYGEN CONCENTRATOR | CAW | INOGEN, INC | IO-300 | 00817131020063 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization |