FDA Adverse Event
Malfunction
Summary report: N
PERFECTO2 V WITH SENSOR 9153650799
MDR report key: 4493965
·
Received February 9, 2015
Report
- Report Number
- 1031452-2015-06500
- Event Type
- Malfunction
- Date Received
- February 9, 2015
- Report Date
- February 2, 2015
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
THE DEALER STATES THIS WAS JUST RECEIVED BACK FROM REPAIR ON RA #(B)(4) IN (B)(6). THE UNIT NOW HAS NO ALARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 92305 | PERFECTO2 V WITH SENSOR 9153650799 | GENERATOR, OXYGEN, PORTABLE | CAW | INVACARE FLORIDA OPERATIONS | IRC5PO2V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |