FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BED
MDR report key: 2842366
·
Received November 9, 2012
Report
- Report Number
- 1824206-2012-07341
- Event Type
- Malfunction
- Date Received
- November 9, 2012
- Date of Event
- October 20, 2012
- Report Date
- October 22, 2012
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM INVESTIGATION FOUND THERE WAS NO PROBLEM WITH SIDERAILS LATCHING. ALL SIDERAILS LATCHED AND LOCKED CORRECTLY.
Description of Event or Problem · 1
CUSTOMER ALLEGED A PATIENT LEANED ON THE RIGHT INTERMEDIATE SIDERAIL RESULTING IN THE RAIL DROPPING WHICH ALLOWED THE PATIENT TO FALL TO THE FLOOR. NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE BED | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |