FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 1963948
·
Received January 12, 2011
Report
- Report Number
- 1824206-2011-00129
- Event Type
- Malfunction
- Date Received
- January 12, 2011
- Date of Event
- February 19, 2008
- Report Date
- February 19, 2008
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN REMOVED THE HYDRAULIC VALVE AND NOTICED IT HAD DEVELOPED SOME MOISTURE WHICH WAS CAUSING THE VALVE TO STICK. THE TECHNICIAN CLEANED THE PISTON AND SPRING ASSEMBLY 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 HEAD OF THE BED WOULD NOT RISE. NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |