FDA Adverse Event
Malfunction
Summary report: N
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
MDR report key: 3061089
·
Received April 16, 2013
Report
- Report Number
- 3004493922-2013-00824
- Event Type
- Malfunction
- Date Received
- April 16, 2013
- Report Date
- March 19, 2013
- Manufacturer
- INVACARE SUZHOU
- Product Code
- BTI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
(B)(4) - THE DEALER REPORTED THAT THE IRC1705 AEROSOL COMPRESSOR WAS INOPERABLE. THERE WAS NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 163744 | PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES | 868.6250 | BTI | INVACARE SUZHOU | IRC1705 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |