FDA Adverse Event
Malfunction
Summary report: N
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
MDR report key: 4120328
·
Received September 26, 2014
Report
- Report Number
- 1031452-2014-11002
- Event Type
- Malfunction
- Date Received
- September 26, 2014
- Date of Event
- June 25, 2014
- Report Date
- June 26, 2014
- Manufacturer
- INVACARE FLORIDA OPERATIONS
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
CONSUMER STATES WHEN HE WAS INSPECTING THE BED HE NOTICED A CABLE IN THE HEAD SECTION OF THE BED WAS VERY FRAYED AND HAD BROKEN WIRES. NO ADDITIONAL INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 601656 | AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS | 880.5100 | FNL | INVACARE FLORIDA OPERATIONS | 5410LOW |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |