FDA Adverse Event
Malfunction
Summary report: N
ENVOY AER COMPRESSOR 230V AUS 9153632953
MDR report key: 4812495
·
Received June 2, 2015
Report
- Report Number
- 3008262382-2015-01238
- Event Type
- Malfunction
- Date Received
- June 2, 2015
- Report Date
- May 4, 2015
- Manufacturer
- INVACARE REHABILITATION EQUIPMENT CO.
- Product Code
- BTI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
FOLLOW UP TO BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
(B)(4) THE NURSE STATES THE MOUTH PIECE AND TUBING NEED REPLACED. SHE STATES THE END USER HAS NOT USED THE AEROSOL COMPRESSOR DUE TO NO SUPPLIES 7857HF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 355824 | ENVOY AER COMPRESSOR 230V AUS 9153632953 | COMPRESSOR, AIR, PORTABLE | BTI | INVACARE REHABILITATION EQUIPMENT CO. | IRC1705 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |