FDA Adverse Event
Malfunction
Summary report: N
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
MDR report key: 3930260
·
Received July 11, 2014
Report
- Report Number
- 3008262382-2014-00262
- Event Type
- Malfunction
- Date Received
- July 11, 2014
- Date of Event
- May 13, 2014
- Report Date
- June 6, 2014
- Manufacturer
- INVACARE REHABILITATION EQUIP
- Product Code
- BTI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER ADVISED UNIT HAS NO AIRFLOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 406102 | PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES | 868.6250 | BTI | INVACARE REHABILITATION EQUIP | IRC1705 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |