FDA Adverse Event
Malfunction
Summary report: N
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
MDR report key: 4093522
·
Received September 16, 2014
Report
- Report Number
- 1031452-2014-09535
- Event Type
- Malfunction
- Date Received
- September 16, 2014
- Report Date
- August 25, 2014
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PER PROVIDER, THE PILOT VALVE IS LEAKING.PER INDEPENDENT REPAIR CENTER STATEMENT, THE UNIT WAS LOW O2 OR YELLOW LIGHT. THE KEY FAILURE WAS PILOT MANIFOLD VALVE WAS LEAKING. ADDITIONAL MALFUNCTIONS WERE PILOT VALVE O-RING ON MANIFOLD DEFECTIVE, CABINET FILTER ON CABINET MISSING COMPONENT AND TIE STRAP 17" ON SIEVE BEDS DEFECTIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573121 | PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) | 868.5440 | CAW | INVACARE FLORIDA OPERATIONS | IRC5PO2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |