FDA Adverse Event
Malfunction
Summary report: N
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
MDR report key: 4090361
·
Received September 15, 2014
Report
- Report Number
- 1031452-2014-09347
- Event Type
- Malfunction
- Date Received
- September 15, 2014
- Date of Event
- August 21, 2014
- Report Date
- August 21, 2014
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PER INDEPENDENT REPAIR CENTER STATEMENT, THE IRC5PO2 CONCENTRATOR HAD LOW O2 (YELLOW LIGHT) AND THE ALARM WOULD NOT FUNCTION. THE KEY FAILURE WAS THE POWER SWITCH HAD NO ALARM. ADDITIONAL MALFUNCTIONS WERE LEAKING BED HOSE, HEAT EXCHANGER AND GEAR CLAMP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 568509 | PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) | 868.5440 | CAW | INVACARE FLORIDA OPERATIONS | IRC5PO2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |