FDA Adverse Event
Malfunction
Summary report: N
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
MDR report key: 3932417
·
Received July 14, 2014
Report
- Report Number
- 1031452-2014-03457
- Event Type
- Malfunction
- Date Received
- July 14, 2014
- Report Date
- June 2, 2014
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- CAW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
PER THE REPAIR STATEMENT THE UNIT ALARMS OR RED LIGHTS AND SOUNDS AN ALARM. TIE WRAPS THAT SECURE THE SIEVE BEDS WERE NOTED TO BE LOOSE AND REPLACED.
Description of Event or Problem · 1
PER PROVIDER TIE WRAPS ARE LOOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 410291 | PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL) | 868.5440 | CAW | INVACARE FLORIDA OPERATIONS | IRC5PO2V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |