FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 2982232
·
Received January 25, 2013
Report
- Report Number
- 1824206-2013-00689
- Event Type
- Malfunction
- Date Received
- January 25, 2013
- Date of Event
- January 21, 2013
- Report Date
- January 21, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH FOUND THE HEAD DOWN BUTTON ON THE PT PENDANT WAS STUCK. THE TECH REPLACED THE HAND HELD PT PENDANT TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE TECH ALLEGED UNINTENTIONAL HEAD DOWN MOVEMENT OF THE BED. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 36358 | VERSACARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |