FDA Adverse Event
Malfunction
Summary report: N
CCU BED
MDR report key: 2052405
·
Received March 16, 2011
Report
- Report Number
- 1824206-2011-01600
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- September 23, 2008
- Report Date
- September 23, 2008
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN REPAIRED BRAKES. NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THIS BED. THIS MDR IS A RESULT OF CAPA ACTIVITY FOR THE RETROSPECTIVE REVIEW OF COMPLAINTS.
Description of Event or Problem · 1
TECHNICIAN ALLEGED THAT THE BRAKES DID NOT FUNCTION PROPERLY. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CCU BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 894 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |