FDA Adverse Event
Malfunction
Summary report: N
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
MDR report key: 3110158
·
Received May 13, 2013
Report
- Report Number
- 1525712-2013-03756
- Event Type
- Malfunction
- Date Received
- May 13, 2013
- Report Date
- April 16, 2013
- Manufacturer
- UNKNOWN
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
THE DEALER REPORTS THAT THE CONCENTRATOR IS NOT ALARMING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210349 | PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) | 868.5440 | CAW | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |