FDA Adverse Event
Malfunction
Summary report: N
ADVANTA II
MDR report key: 2243455
·
Received August 29, 2011
Report
- Report Number
- 3006697241-2011-00095
- Event Type
- Malfunction
- Date Received
- August 29, 2011
- Date of Event
- August 17, 2011
- Report Date
- August 17, 2011
- Manufacturer
- HILL-ROM DE MEXICO S DE RL DE CV
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH FOUND THE SCREWS WERE STRIPPED OUT OF PLASTIC MOLDED SIDERAIL PANEL. HE REPLACED THE RIGHT FOOT SIDERAIL ASSEMBLY TO REPAIR THE BED.
Description of Event or Problem · 1
THE ACCOUNT STATED WHEN THE PT'S FOOT PUSHED THE FOOT SIDERAIL; THE PLASTIC PANEL FELL OFF THE BED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANTA II | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM DE MEXICO S DE RL DE CV | 1190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |