FDA Adverse Event
Summary report: N
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
MDR report key: 2893889
·
Received January 2, 2013
Report
- Report Number
- 1531186-2013-00017
- Date Received
- January 2, 2013
- Report Date
- January 2, 2013
- Manufacturer
- MEDEL S.P.A.
- Product Code
- BTI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
ON (B)(6) -THE DEALER REPORTED THAT THE IRC1710 AEROSOL COMPRESSOR WAS NOT FUNCTIONING. THERE WAS NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 536 | PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES | 868.6250 | BTI | MEDEL S.P.A. | IRC1710 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |