FDA Adverse Event
Malfunction
Summary report: N
ADVANTA 2 BED
MDR report key: 2850094
·
Received October 23, 2012
Report
- Report Number
- 3006697241-2012-00253
- Event Type
- Malfunction
- Date Received
- October 23, 2012
- Date of Event
- October 4, 2012
- Report Date
- October 4, 2012
- Manufacturer
- HILL-ROM DE MEXICO S DE RL DE CV
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT REPLACED THE SIDE RAIL WELDMENT TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THE WELD ON THE SIDE RAIL IS BROKEN AND THE SIDE RAIL WILL NOT LATCH. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANTA 2 BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM DE MEXICO S DE RL DE CV | 1190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |