FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BARIATRIC PLUS BED
MDR report key: 3101694
·
Received April 30, 2013
Report
- Report Number
- 1824206-2013-02417
- Event Type
- Malfunction
- Date Received
- April 30, 2013
- Date of Event
- April 4, 2013
- Report Date
- April 4, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT FOUND A STICKY SUBSTANCE IN THE SIDE RAIL CENTER ARM ASSEMBLY. THE ACCOUNT CLEANED AND LUBRICATED THE SIDE RAIL LATCH MECHANISM TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THE SIDE RAIL WILL NOT STAY LATCHED. NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 187773 | TOTALCARE BARIATRIC PLUS BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |