FDA Adverse Event
Malfunction
Summary report: N
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
MDR report key: 4090188
·
Received September 15, 2014
Report
- Report Number
- 1031452-2014-09339
- Event Type
- Malfunction
- Date Received
- September 15, 2014
- Report Date
- August 27, 2014
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- FNL
- Adverse Event
- Yes
- 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
TERRITORY BUSINESS MANAGER (TBM) STATED THAT THE END USER SLEEPS IN THE FETAL POSITION A MAJORITY OF THE DAY ON A 5410IVC FULL ELECTRIC BED. USER'S DAUGHTER REPORTED THAT THE MATTRESS APPEARS TO BE SAGGING IN THE MIDDLE, END USER IS EXPERIENCING BACK PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 568256 | AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS | 880.5100 | FNL | INVACARE FLORIDA OPERATIONS | 5410IVC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |