FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 2030605
·
Received March 22, 2011
Report
- Report Number
- 1824206-2011-01775
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Date of Event
- February 28, 2011
- Report Date
- February 28, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICAL SUPPORT INSTRUCTED THE ACCOUNT TO REPLACE THE PENDANT. REPAIRS HAVE NOT BEEN COMPLETED.
Description of Event or Problem · 1
THE ACCOUNTS ENGINEER ALLEGED THAT HE HAS APPROXIMATELY 5 OR 6 PENDANTS THAT ARE HAVING A PROBLEM WITH THE CABLES PULLING AWAY FROM THE BODY OF THE PENDANT. BARE METAL WIRES WERE VISIBLE ON ONE PENDANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSACARE BED | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |