FDA Adverse Event
Malfunction
Summary report: N
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
MDR report key: 4191658
·
Received October 22, 2014
Report
- Report Number
- 1031452-2014-15388
- Event Type
- Malfunction
- Date Received
- October 22, 2014
- Report Date
- October 2, 2014
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PER INDEPENDENT REPAIR CENTER STATEMENT THE UNIT HAD LOW O2 OR YELLOW LIGHT. THE KEY FAILURE WAS THE SIEVE BEDS WERE SATURATED. ADDITIONAL MALFUNCTIONS INCLUDE THE FILLING RECEPTACLES WERE DEFECTIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 674101 | PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) | 868.5440 | CAW | INVACARE FLORIDA OPERATIONS | IRC5PO2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |