FDA Adverse Event
Malfunction
Summary report: N
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
MDR report key: 3071899
·
Received April 22, 2013
Report
- Report Number
- 1031452-2013-00764
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Report Date
- March 26, 2013
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
CONSUMER STATES FOOTSPRING DOES NOT STAY UP WHEN YOU RAISE IT. IT ENDS UP FALLING EVENTUALLY. MATTRESS IS SAGGING AND SHE SLEEPS IN A HOLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172835 | AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS | 880.5100 | FNL | INVACARE FLORIDA OPERATIONS | 5310 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 | Other |