FDA Adverse Event
Malfunction
Summary report: N
INOGEN, INC
MDR report key: 21688551
·
Received March 25, 2025
Report
- Report Number
- 3004672275-2024-00108
- Event Type
- Malfunction
- Date Received
- March 25, 2025
- Date of Event
- November 29, 2024
- Report Date
- December 23, 2024
- Manufacturer
- INOGEN, INC
- Product Code
- CAW
- UDI-DI
- 00817131020063
- PMA / PMN Number
- K032818
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE PATIENT HAS BEEN CONTACTED FOR FOLLOW-UP, AND THE PATIENT'S SON IS EXPECTED TO PROVIDE FURTHER INFORMATION REGARDING THEIR CONDITION.
Description of Event or Problem · 0
THE PATIENT STATED THAT THE UNIT HAS BEEN MAKING NOISES, OVERHEATING, AND SHUTTING DOWN MULTIPLE TIMES. T UNIT NEEDED NEW COLUMNS. THE PATIENT ALSO REPORTED A SYSTEM ERROR AND SENSOR ERROR FAILURE. THE PATIENT REQUIRED HOSPITALIZATION FOR TREATMENT. THE REPORTED EVENTS ARE RELATED TO ASSEMBLY CONCENTRATOR G3HF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1133120 | INOGEN, INC | INOGEN ONE G3HF | CAW | INOGEN, INC | IO-300 | 00817131020063 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization |