FDA Adverse Event
Malfunction
Summary report: N
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
MDR report key: 3112802
·
Received May 14, 2013
Report
- Report Number
- 1525712-2013-03792
- Event Type
- Malfunction
- Date Received
- May 14, 2013
- Report Date
- April 18, 2013
- Manufacturer
- UNKNOWN
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
END USER, MICHELLE, ALLEGED THAT THE BOLT TO THE RAILS CAME OFF. ALSO STATED THAT THE HAND CRANK FELL OFF AS WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 212435 | AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS | 880.5100 | FNL | UNKNOWN | 6630 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |