FDA Adverse Event
Malfunction
Summary report: N
TOTAL CARE BED
MDR report key: 3882835
·
Received February 21, 2014
Report
- Report Number
- 1824206-2014-00571
- Event Type
- Malfunction
- Date Received
- February 21, 2014
- Date of Event
- January 26, 2014
- Report Date
- January 26, 2014
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE TECH FOUND DEBRIS IN THE RIGHT FOOT SIDE RAIL LATCHING MECHANISM CAUSING IT TO STICK. THE TECH CLEANED THE RIGHT FOOT SIDE RAIL LATCHING MECHANISM TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE ACCOUNT REPORTED THE RIGHT FOOT SIDE RAIL WILL NOT STAY LATCHED. THE BED WAS LOCATED IN THE REPAIR AREA AT THE FACILITY. THERE WAS NO PT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110562 | TOTAL CARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |