FDA Adverse Event
Malfunction
Summary report: N
PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963
MDR report key: 4785320
·
Received May 20, 2015
Report
- Report Number
- 1031452-2015-13832
- Event Type
- Malfunction
- Date Received
- May 20, 2015
- Report Date
- April 30, 2015
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
DEVICE RETURNED FOR EVALUATION. FAILURE MODES: 4-WAY VALVE 1101141 STUCK, MANIFOLD (B)(4).
Additional Manufacturer Narrative · 1
NO END USER INFORMATION PROVIDED. A FOLLOW-UP WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
DEALER ALLEGES UNIT HAS A LOCKED COMPRESSOR. RED LIGHT AND ALARM KICKS THE RESET BUTTON. INTERMITTENT START UP ALARM. NO FURTHER INFORMATION PROVIDED BY DEALER.
Description of Event or Problem · 1
DEALER ALLEGES UNIT HAS A LOCKED COMPRESSOR. RED LIGHT AND ALARM KICKS THE RESET BUTTON. INTERMITTENT START UP ALARM. NO FURTHER INFORMATION PROVIDED BY DEALER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 329220 | PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963 | GENERATOR, OXYGEN, PORTABLE | CAW | INVACARE FLORIDA OPERATIONS | IRC5PO2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |