FDA Adverse Event
Malfunction
Summary report: N
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
MDR report key: 3163564
·
Received June 11, 2013
Report
- Report Number
- 1031452-2013-01098
- Event Type
- Malfunction
- Date Received
- June 11, 2013
- Report Date
- May 14, 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
PROVIDER ALLEGED THE FRAME BROKE AND IT WAS NOT AT A WELD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 264824 | AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS | 880.5100 | FNL | INVACARE FLORIDA OPERATIONS | 5410IVC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |