FDA Adverse Event
Malfunction
Summary report: N
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
MDR report key: 2970035
·
Received February 20, 2013
Report
- Report Number
- 3004493922-2013-00393
- Event Type
- Malfunction
- Date Received
- February 20, 2013
- Report Date
- February 19, 2013
- Manufacturer
- INVACARE SUZHOU
- Product Code
- BTI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER STATED THAT THERE IS LOW PSI PRESSURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 74163 | PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES | 868.6250 | BTI | INVACARE SUZHOU | IRC1705 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |