FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 3882795
·
Received February 20, 2014
Report
- Report Number
- 1824206-2014-00556
- Event Type
- Malfunction
- Date Received
- February 20, 2014
- Date of Event
- January 24, 2014
- Report Date
- January 24, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE BRAKE CASTERS WERE WORN. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2013. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECH REPLACED THE BRAKE CASTERS TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
HILL-ROM RECEIVED A REPORT FROM A HILL-ROM TECH STATING THE BRAKES WERE NOT HOLDING (THE HEAD CASTER AND BOTH FOOT CASTERS STILL SWIVELED WHEN THE BRAKES WERE SET). THERE WAS NO PT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106930 | VERSACARE BED | A/C POWERED ADJUSTABLE HOSP BED | FNL | HILL-ROM, INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |