FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 3190182
·
Received June 10, 2013
Report
- Report Number
- 1824206-2013-03006
- Event Type
- Malfunction
- Date Received
- June 10, 2013
- Date of Event
- May 20, 2013
- Report Date
- May 20, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE BED EXIT ALARM IS INOPERABLE. THE TECHNICIAN REPLACED THE SCALE POWER CONTROL BOARD AND INSTALLED AN EXTERNAL ALARM TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THE BED EXIT ALARM IS TOO LOW. NO PT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 261916 | VERSACARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |