FDA Adverse Event
Malfunction
Summary report: N
CCU BED W/SCALE
MDR report key: 1993252
·
Received January 21, 2011
Report
- Report Number
- 1824206-2011-00384
- Event Type
- Malfunction
- Date Received
- January 21, 2011
- Date of Event
- April 6, 2008
- Report Date
- April 6, 2008
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN FOUND THAT THE BRAKE CASTERS WERE WORN DUE TO AGE. THE TECHNICIAN REPLACED THE BRAKE CASTERS AND THE BRAKES FUNCTIONED PROPERLY. THIS MDR IS A RESULT OF CAPA ACTIVITY FOR THE RETROSPECTIVE REVIEW OF COMPLAINTS.
Description of Event or Problem · 1
TECHNICIAN ALLEGED THAT THE BRAKE CASTERS DID NOT HOLD IN THE BRAKE MODE. NO ALLEGED INJURIES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CCU BED W/SCALE | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 894 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |