FDA Adverse Event
Malfunction
Summary report: N
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
MDR report key: 3222822
·
Received July 12, 2013
Report
- Report Number
- 1525712-2013-05689
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Report Date
- June 20, 2013
- Manufacturer
- UNKNOWN
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
MODEL NUMBER 6629 APPLIES TO THE BED RAILS.
Description of Event or Problem · 1
THE PROVIDER STATED THE CROSSBRACE BROKE AT THE WELD POINT WHERE THE RAIL SITS INTO THE CROSSBRACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322843 | AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS | 880.5100 | FNL | UNKNOWN | 6629 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |