FDA Adverse Event
Malfunction
Summary report: N
ADVANTA II
MDR report key: 2222976
·
Received August 16, 2011
Report
- Report Number
- 3006697241-2011-00082
- Event Type
- Malfunction
- Date Received
- August 16, 2011
- Date of Event
- August 4, 2011
- Report Date
- August 4, 2011
- Manufacturer
- HILL-ROM DE MEXICO S DE RL DE CV
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN REPLACED THE SIDERAIL AND MOUNTING SCREWS TO REPAIR THE BED.
Description of Event or Problem · 1
INFO RECEIVED INDICATES, THE LEFT FOOT SIDERAIL BROKE OFF FROM THE SIDERAIL ARM. THE MOUNTING HOLES IN THE SIDERAIL WERE STRIPPED WHERE THE SCREWS HOLD SIDERAIL IN PLACE TO THE ARM.
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 |