FDA Adverse Event
Malfunction
Summary report: N
AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
MDR report key: 2882717
·
Received December 20, 2012
Report
- Report Number
- 3003433498-2012-00112
- Event Type
- Malfunction
- Date Received
- December 20, 2012
- Report Date
- December 19, 2012
- Manufacturer
- CARROLL HEALTHCARE
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
A (B)(6) REPORTED THAT THE RESIDENT WAS LYING ON THE BED WHILE THE HEIGHT WAS BEING ADJUSTED WITH THE CONTROLLER AND THE ENTIRE BED COLLAPSED. IT WAS LEARNED THAT THE CRANK THAT GOES INTO THE MOTOR THAT CHANGES THE HEIGHT OF THE BED IS THE ISSUE. THE BED IS APPROX. 9 YEARS. OLD AND ONLY ONE RESIDENT USES THE BED DAILY. THE BED IS NOT PRESENTLY IN USE BUT REMAINS AT THE NURSING HOME. NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS | 880.5100 | FNL | CARROLL HEALTHCARE | SOLO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |