FDA Adverse Event
Malfunction
Summary report: N
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
MDR report key: 3123238
·
Received May 21, 2013
Report
- Report Number
- 1031452-2013-00950
- Event Type
- Malfunction
- Date Received
- May 21, 2013
- Date of Event
- April 25, 2013
- Report Date
- April 25, 2013
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
POTENTIAL FOR INJURY ASSOCIATED WITH XPO100B CONCENTRATOR SHUTTING DOWN UNEXPECTEDLY WITHOUT ALARMING. THIS COULD CAUSE THE USER NOT TO BE WARNED TO SWITCH TO AN ALTERNATIVE SOURCE OF OXYGEN. THIS IS NOT A LIFE-SUSTAINING DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224062 | PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) | 868.5440 | CAW | INVACARE FLORIDA OPERATIONS | XPO100B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |