FDA Adverse Event
Malfunction
Summary report: N
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
MDR report key: 3970436
·
Received July 31, 2014
Report
- Report Number
- 3008262382-2014-00446
- Event Type
- Malfunction
- Date Received
- July 31, 2014
- Report Date
- June 27, 2014
- Manufacturer
- INVACARE REHABILITATION EQUIP
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
PROVIDER ALLEGED UNIT WILL RUN ABOUT 1 TO 2 HOURS AND RED LIGHT AND ALARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 448120 | PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) | 868.5440 | CAW | INVACARE REHABILITATION EQUIP | IRC5P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |