FDA Adverse Event
Malfunction
Summary report: N
CCU BED W/ SCALE
MDR report key: 1993583
·
Received January 24, 2011
Report
- Report Number
- 1824206-2011-00397
- Event Type
- Malfunction
- Date Received
- January 24, 2011
- Date of Event
- April 23, 2008
- Report Date
- April 23, 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 REPLACED THREE BRAKES CASTERS TO RESOLVE THE ISSUE. THIS MDR IS A RESULT OF CAPA ACTIVITY FOR THE RETROSPECTIVE REVIEW OF COMPLAINTS.
Description of Event or Problem · 1
TECHNICIAN ALLEGED, THE BRAKES ARE NOT WORKING CORRECTLY, BRAKES ARE NOT HOLDING. NO PT IMPACT.
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 |