FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BARIATRIC
MDR report key: 3060458
·
Received March 25, 2013
Report
- Report Number
- 1824206-2013-01655
- Event Type
- Malfunction
- Date Received
- March 25, 2013
- Date of Event
- February 25, 2013
- Report Date
- February 25, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECH FOUND THAT THE LOCKING MECHANISM WAS BROKEN. HE REPLACED THE LOCKING MECHANISM TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
INFORMATION INDICATED THE LEFT INTERMEDIATE SIDE RAIL WILL NOT LATCH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 122682 | TOTALCARE BARIATRIC | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |