FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 3882793
·
Received February 20, 2014
Report
- Report Number
- 1824206-2014-00554
- Event Type
- Malfunction
- Date Received
- February 20, 2014
- Date of Event
- January 23, 2014
- Report Date
- January 23, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICIAN THOROUGHLY TESTED THE NURSE CALL FUNCTIONS AND NO ISSUES WERE FOUND . THE BED FUNCTIONED AS DESIGNED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2008-2010 AND 2012-2013. IT IS UNK IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THERE WERE NO ISSUES FOUND. 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 BED HAD A NOTE ON IT THAT THE NURSE CALL WOULD NOT WORK. THE BED WAS LOCATED IN 4 NORTH. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 107206 | VERSACARE BED | A/C POWERED ADJUSTABLE HOSP BED | FNL | HILL-ROM, INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |