FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 2050458
·
Received March 15, 2011
Report
- Report Number
- 1824206-2011-01597
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- February 21, 2011
- Report Date
- February 21, 2011
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THAT A SMALL AMOUNT OF HYDRAULIC FLUID WAS LEAKING INSIDE OF THE BED FRAME. NO FLUID LEAKED ONTO THE FLOOR. HE DISCOVERED THAT THE SEALS ON THE HYDRAULIC RESERVOIR WERE ALLOWING A SMALL AMOUNT OF FLUID TO ESCAPE DUE TO NORMAL WEAR. ALL BED FUNCTIONS WERE OPERATING AS DESIGNED. THE TECHNICIAN REPLACED THE RESERVOIR W/ SEALS, THE BREATHER CAP AND REPLACED THE HYDRAULIC FLUID TO REPAIR THE BED.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THE BED HAS NO HEAD UP FUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |