FDA Adverse Event
Malfunction
Summary report: N
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
MDR report key: 4242580
·
Received November 11, 2014
Report
- Report Number
- 3008262382-2014-01939
- Event Type
- Malfunction
- Date Received
- November 11, 2014
- Report Date
- October 22, 2014
- Manufacturer
- INVACARE REHABILITATION EQUIP
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PER INDEPENDENT REPAIR CENTER STATEMENT ALLEGED ALARMING THE KEY FAILURE IS THE MANIFOLD VALVE IS NOT SHIFTING FULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 727668 | PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) | 868.5440 | CAW | INVACARE REHABILITATION EQUIP | IRC5P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |