FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 1821812
·
Received August 26, 2010
Report
- Report Number
- 1824206-2010-09587
- Event Type
- Malfunction
- Date Received
- August 26, 2010
- Date of Event
- August 3, 2010
- Report Date
- August 3, 2010
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF THE PIN COMES OUT, THE SIDERAIL CENTER ARM ASSEMBLY WOULD BREAK AROUND THE PIN AND PREVENT THE SIDERAIL FROM LATCHING. REPAIRS HAVE NOT BEEN COMPLETED.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THE LEFT SIDERAIL LOWER CENTER ARM ASSEMBLY IS BROKEN. THE ACCOUNT INDICATED THE COVER AND THE SHORT PIN ARE MISSING ON THE RAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERSACARE BED | AC POWERED HOSPITAL BED | FNL | HILL-ROM INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |