FDA Adverse Event
Malfunction
Summary report: N
PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963
MDR report key: 4501490
·
Received February 10, 2015
Report
- Report Number
- 1031452-2015-06660
- Event Type
- Malfunction
- Date Received
- February 10, 2015
- Report Date
- February 3, 2015
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
INITIAL MFG REPORT # 1031452-2015-06660 WAS SUBMITTED TO THE FDA ON 02/10/2015. (B)(4).
Description of Event or Problem · 1
DEALER REPORTED THAT THE PILOT VALVES WERE REPLACED WHEN THE IRC5PO2V CONCENTRATOR DISPLAYED 1 RED AND 2 GREEN INDICATOR LIGHTS AND SHUT DOWN. DEALER STATED THAT THE SIEVE BEDS WERE "BLOWN" WITH WHITE DUST FILLING THE LOWER TUBES. DEALER ALSO STATED THAT THE POWER SWITCH FAILED TO ENABLE ALARM HORNS. THE DEALER STATED SIEVE BEDS WERE "BLOWN" WITH DUST FILLING LOWER TUBES. THE DEALER STATED POWER SWITCHES FAILED TO ENABLE ALARM HORNS.
Description of Event or Problem · 1
DEALER IS SWAPPING OUT ALL PILOT VALVES WITH NEW PART # 2003052 UNDER WARRANTY ALONG WITH O'RINGS. DEALER ALLEGES UNITS WHERE SHUTTING DOWN WITH TWO GREEN AND ONE RED ERROR CODE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93737 | PERFECTO2 OXYGEN CONCENTRATOR WITH SENSO2 9153646963 | GENERATOR, OXYGEN, PORTABLE | CAW | INVACARE FLORIDA OPERATIONS | IRC5PO2V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |