FDA Adverse Event
Malfunction
Summary report: N
FULL ELECTRIC FOOT SPRING 9153638201
MDR report key: 4733816
·
Received April 28, 2015
Report
- Report Number
- 1031452-2015-13655
- Event Type
- Malfunction
- Date Received
- April 28, 2015
- Report Date
- April 20, 2015
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
TBM STATES ONE OF THE WELDS HAS POPPED, BECAUSE THE FOOT SECTION WILL NOT LAY FLAT, IT LAYS UP HIGHER ON THE RIGHT SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 278576 | FULL ELECTRIC FOOT SPRING 9153638201 | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | INVACARE FLORIDA OPERATIONS | 5410IVC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |