FDA Adverse Event
Summary report: N
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
MDR report key: 2863887
·
Received December 10, 2012
Report
- Report Number
- 1531186-2012-01691
- Date Received
- December 10, 2012
- Report Date
- December 7, 2012
- Manufacturer
- MEDEL S.P.A.
- Product Code
- BTI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4) - NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES THE ON/OFF BUTTON IS FROZEN ON THE COMPRESSOR. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES | 868.6250 | BTI | MEDEL S.P.A. | IRC1710 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |