FDA Adverse Event
Malfunction
Summary report: N
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
MDR report key: 4211221
·
Received October 29, 2014
Report
- Report Number
- 1031452-2014-16493
- Event Type
- Malfunction
- Date Received
- October 29, 2014
- Report Date
- October 8, 2014
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
INDEPENDENT REPAIR CENTER CUSTOMER ALLEGED UNIT HAS LOW O2 OR YELLOW LIGHT. NOTED IN THE REPAIR DOC THERE WAS LOOSE CABLE TIES TIGHTENED, AND REPAIRED LEAKS ON THE PE VALVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 692388 | PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) | 868.5440 | CAW | INVACARE FLORIDA OPERATIONS | IRC5PO2V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |