FDA Adverse Event
Malfunction
Summary report: N
ADVANCE BED
MDR report key: 2080211
·
Received April 6, 2011
Report
- Report Number
- 1824206-2011-02043
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- March 15, 2011
- Report Date
- March 15, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ACCOUNT FOUND A DEFECTIVE WELD ON THE BRAKE CASTER STEM. WELD BROKE ON THE BASE FRAME. THE ACCOUNT REPLACED THE BASE FRAME TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
ACCOUNT ALLEGED THE LEFT FRONT BRAKE CASTER STEM WELD WAS BROKE ON THE BASE FRAME. NO INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANCE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1165 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |