FDA Adverse Event
Malfunction
Summary report: N
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
MDR report key: 3178593
·
Received June 19, 2013
Report
- Report Number
- 1031452-2013-01154
- Event Type
- Malfunction
- Date Received
- June 19, 2013
- Report Date
- May 23, 2013
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MFR. REPORT # 1031452-2013-01154. THIS WAS AN NON-REPORTABLE EVENT. INFORMATION INDICATES THAT THE IRC5P CONCENTRATOR ALARMED AS DESIGNED PRIOR TO SHUT DOWN. THE USER WAS ALERTED TO SWITCH TO AN ALTERNATE SOURCE OF OXYGEN AND TO SEEK REPAIRS. THIS IS NOT A LIFE SUPPORT / LIFE SUSTAINING DEVICE, BUT AN OXYGEN SUPPLEMENT.
Description of Event or Problem · 1
DEALER STATING UNIT IS SHUTTING DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 277648 | PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) | 868.5440 | CAW | INVACARE FLORIDA OPERATIONS | IRC5P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |