FDA Adverse Event
Malfunction
Summary report: N
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
MDR report key: 4203083
·
Received October 27, 2014
Report
- Report Number
- 1031452-2014-16270
- Event Type
- Malfunction
- Date Received
- October 27, 2014
- Report Date
- October 6, 2014
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
INDEPENDENT REPAIR CENTER: CUSTOMER ALLEGED IS NOT LISTED AND THE KEY FAILURE IS THE CHECK VALVE ASSEMBLY IS LEAKING.AS STATED IN THE INDEPENDENT REPAIR STATEMENT FAXED ORDER #(B)(4) ADDITIONAL MALFUNCTION ON THIS DEVICE: NO LOW FLOW ALARM, GEAR CLAMP ON MANIFOLD HAS A LOOSE HOSE, AND CABINET FILTER IS MISSING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 681881 | PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) | 868.5440 | CAW | INVACARE FLORIDA OPERATIONS | IRC10LXO2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |