FDA Adverse Event
Malfunction
Summary report: N
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
MDR report key: 2998516
·
Received March 11, 2013
Report
- Report Number
- 1031452-2013-00526
- Event Type
- Malfunction
- Date Received
- March 11, 2013
- Report Date
- February 12, 2013
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4) 2013 - RBS -THE DEALER REPORTED THAT THE (B)(4) STATIONARY CONCENTRATOR HAD OIL SPILLED ON, THERE WAS NO SCREWS ATTACHING THE COVER TO THE UNIT, AND WHEN IT WAS LOGGED ON, IT WOULD TRIGGER THE RESET SWITCH. THERE WAS NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 101573 | PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) | 868.5440 | CAW | INVACARE FLORIDA OPERATIONS | IRC5PO2V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |