FDA Adverse Event
Malfunction
Summary report: N
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
MDR report key: 3790769
·
Received May 5, 2014
Report
- Report Number
- 3003433498-2014-00079
- Event Type
- Malfunction
- Date Received
- May 5, 2014
- Report Date
- April 1, 2014
- Manufacturer
- CARROLL HEALTHCARE
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DEALER STATED THAT THE BED RAIL ON AN ARRO (CARROLL HEALTHCARE) BED HAS A SHARP EDGE ON THE BOTTOM OF THE RAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 267622 | AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS | 880.5100 | FNL | CARROLL HEALTHCARE | ARRO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |