FDA Adverse Event
Malfunction
Summary report: N
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
MDR report key: 3090518
·
Received May 2, 2013
Report
- Report Number
- 1031452-2013-00833
- Event Type
- Malfunction
- Date Received
- May 2, 2013
- Report Date
- April 8, 2013
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED.PER DEALER THE WIRE IS COMING OUT OF STRAIN RELIEF.MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192035 | AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS | 880.5100 | FNL | INVACARE FLORIDA OPERATIONS | 5410LOW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |