FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BARIATRIC
MDR report key: 3012720
·
Received February 22, 2013
Report
- Report Number
- 1824206-2013-01078
- Event Type
- Malfunction
- Date Received
- February 22, 2013
- Date of Event
- January 27, 2013
- Report Date
- January 27, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECH FOUND THE BRAKE/STEER TORQUE WELDMENT BAR WAS STRIPPED. THE HILL-ROM TECH REPLACED THE BRAKE STEER TORQUE WELDMENT TUBE TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
INFO RECEIVED INDICATED THE BRAKES WOULD NOT HOLD WHEN SET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78826 | TOTALCARE BARIATRIC | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |