FDA Adverse Event
Malfunction
Summary report: N
INOGEN ROVE 6 PORTABLE OXYGEN CONCENTRATOR
MDR report key: 19843135
·
Received July 26, 2024
Report
- Report Number
- 3004672275-2024-00051
- Event Type
- Malfunction
- Date Received
- July 26, 2024
- Date of Event
- June 27, 2024
- Report Date
- July 26, 2024
- Manufacturer
- INOGEN, INC.
- Product Code
- CAW
- UDI-DI
- 00817131020513
- PMA / PMN Number
- K230052
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
A REQUEST FOR FURTHER INFORMATION HAS BEEN INITIATED. ONCE THE DEVICE AND MORE INFORMATION IS RECEIVED AN INVESTIGATION WILL BE CONDUCTED AND A FOLLOW UP WILL BE SUBMITTED IF REQUIRED.
Description of Event or Problem · 0
ACCORDING TO THE PATIENT, THE POC GOT HOT AND BURNED THE PATIENT. THE PATIENT HAS NOT RESPONDED TO CALLS OR EMAILS REQUESTING FURTHER INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1776290 | INOGEN ROVE 6 PORTABLE OXYGEN CONCENTRATOR | INOGEN ROVE 6 PORTABLE OXYGEN CONCENTRATOR | CAW | INOGEN, INC. | IO-501 | 00817131020513 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |