FDA Adverse Event
Malfunction
Summary report: N
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
MDR report key: 4212375
·
Received October 30, 2014
Report
- Report Number
- 1531186-2014-05202
- Event Type
- Malfunction
- Date Received
- October 30, 2014
- Report Date
- October 9, 2014
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PER INDEPENDENT REPAIR CENTER STATEMENT ALLEGED ALARMING THE KEY FAILURE IS THE SIEVE BEDS ARE SATURATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 695634 | PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) | 868.5440 | CAW | INVACARE FLORIDA OPERATIONS | IRC5PO2W |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |