FDA Adverse Event
Malfunction
Summary report: N
CCU BED
MDR report key: 2031724
·
Received March 21, 2011
Report
- Report Number
- 1824206-2011-01742
- Event Type
- Malfunction
- Date Received
- March 21, 2011
- Date of Event
- February 24, 2011
- Report Date
- February 24, 2011
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE BED IN A LOW FLAT POSITION. HE FOUND THE CONNECTION BETWEEN THE RELEASE ROD AND THE CONNECTOR WAS BROKEN. HE REPLACED THE RELEASE ROD AND THE HEX CONNECTOR TO REPAIR THE BED.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES THE TRENDELENBURG FUNCTION IS NOT WORKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CCU BED | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 894 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |