FDA Adverse Event
Malfunction
Summary report: N
CCU BED W/ SCALE
MDR report key: 1993584
·
Received January 24, 2011
Report
- Report Number
- 1824206-2011-00398
- Event Type
- Malfunction
- Date Received
- January 24, 2011
- Date of Event
- April 25, 2008
- Report Date
- April 25, 2008
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH REPLACED THE BRAKE AND STEER 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
TECH ALLEGED THAT THE STEER AND BRAKE CASTER DID NOT HOLD. 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 |