FDA Adverse Event
Malfunction
Summary report: N
ADVANTA II
MDR report key: 2231641
·
Received August 24, 2011
Report
- Report Number
- 3006697241-2011-00087
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Date of Event
- August 1, 2011
- Report Date
- August 1, 2011
- Manufacturer
- HILL-ROM DE MEXICO S DE RL DE CV
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A NEW SIDERAIL ASSEMBLY WAS SENT TO THE ACCOUNT TO REPAIR THE BED.
Description of Event or Problem · 1
THE ACCOUNTS MAINTENANCE STATED THE RIGHT FOOT SIDERAIL JUST CAME OFF FROM THE MOUNTING BRACKET LIKE THE SCREWS WERE JUST STRIPPED. HE SAID THERE ARE NO SIGNS OF ABUSE.
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 |