FDA Adverse Event
Summary report: N
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
MDR report key: 4220229
·
Received November 3, 2014
Report
- Report Number
- 1531186-2014-05279
- Date Received
- November 3, 2014
- Date of Event
- August 29, 2014
- Report Date
- October 9, 2014
- Manufacturer
- RESPIRONICS INC
- Product Code
- BTI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER ADVISED UNIT IS OVERHEATING WITH A LOUD NOISE, RETURN FOR CREDIT ONLY, (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702078 | PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES | 868.6250 | BTI | RESPIRONICS INC | IRC1710 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |