FDA Adverse Event
Malfunction
Summary report: N
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
MDR report key: 3103596
·
Received May 9, 2013
Report
- Report Number
- 1031452-2013-00882
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Report Date
- April 15, 2013
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
DEALER STATED THE WELD BROKE ON THE HEADSPRING WHERE THE MOTOR CONNECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204314 | AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS | 880.5100 | FNL | INVACARE FLORIDA OPERATIONS | BED10-1633 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |