FDA Adverse Event
Malfunction
Summary report: N
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
MDR report key: 4039930
·
Received August 27, 2014
Report
- Report Number
- 1031452-2014-07472
- Event Type
- Malfunction
- Date Received
- August 27, 2014
- Report Date
- August 4, 2014
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC
- 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 BEING DEFECTIVE. ADDITIONAL MALFUNCTIONS WERE 2 MD HOSE CLAMPS WERE INSTALLED, ON/OFF SWITCH HAD NO ALARM AND 8 TIE WRAPS WERE INSTALLED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 522207 | PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) | 868.5440 | CAW | INVACARE FLORIDA OPERATIONS | IRC5PO2V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |