FDA Adverse Event
Malfunction
Summary report: N
ADVANTA BED
MDR report key: 3112218
·
Received May 3, 2013
Report
- Report Number
- 1824206-2013-02466
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Date of Event
- April 3, 2013
- Report Date
- April 3, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH FOUND A BROKEN SWING ARM WELDMENT ON THE SIDE RAIL. THE TECH REPLACED THE SIDE RAIL TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE TECH ALLEGED THAT THE SIDE RAIL IS NOT STAYING UP. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 195652 | ADVANTA BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |