FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 1163380
·
Received September 10, 2008
Report
- Report Number
- 1824206-2008-03373
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- August 1, 2008
- Report Date
- August 1, 2008
- Manufacturer
- HILL-ROM, RITTER
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER STATED THAT NONE OF THE HYDRAULIC FUNCTIONS WERE WORKING. FOUND THE HYDRAULIC RESERVOIR TANK WAS EMPTY OF ALL FLUID. AND, THERE WAS EVIDENCE OF LEAKAGE FROM MANIFOLD. REPLACED HYDRAULIC MANIFOLD TO RESOLVE ISSUE, NO INJURY BEING REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC POWERED HOSPITAL BED | FNL | HILL-ROM, RITTER | 1900 | P1900AF1619 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |