FDA Adverse Event
Summary report: N
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
MDR report key: 2843255
·
Received November 21, 2012
Report
- Report Number
- 1531186-2012-01445
- Date Received
- November 21, 2012
- Report Date
- November 21, 2012
- Manufacturer
- MEDEL S.P.A.
- Product Code
- BTI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
MDR DECISION DATE: (B(6) 2012. NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PROVIDER STATES COMPRESSOR STARTS BUT SHUTS OFF. UNKNOWN REASON WHY. 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 |