FDA Adverse Event
Malfunction
Summary report: N
PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES
MDR report key: 3974818
·
Received August 4, 2014
Report
- Report Number
- 3008262382-2014-00450
- Event Type
- Malfunction
- Date Received
- August 4, 2014
- Report Date
- June 26, 2014
- Manufacturer
- INVACARE REHABILITATION EQUIP
- Product Code
- BTI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
CLAIMANT ALLEGED THAT LAST NIGHT THE UNIT STOPPED MISTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 453353 | PORTABLE AIR COMPRESSOR FOR MEDICAL PURPOSES | 868.6250 | BTI | INVACARE REHABILITATION EQUIP | IRC1705 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 | Other |