FDA Adverse Event
Malfunction
Summary report: N
TOTCALCARE BED
MDR report key: 2823771
·
Received October 10, 2012
Report
- Report Number
- 1824206-2012-06355
- Event Type
- Malfunction
- Date Received
- October 10, 2012
- Date of Event
- April 25, 2012
- Report Date
- April 25, 2012
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN ISOLATED THE ISSUE TO A WORN SEAL ON THE HYDRAULIC MANIFOLD. THE TECHNICIAN REPLACED THE HYDRAULIC MANIFOLD ASSEMBLY TO REPAIR THE BED.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES THE HEAD OF THE BED IS SLOWLY DRIFTING DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTCALCARE BED | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |