FDA Adverse Event
Malfunction
Summary report: N
TOTAL CARE BARIATRIC BED
MDR report key: 2080169
·
Received April 6, 2011
Report
- Report Number
- 1824206-2011-02028
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- March 14, 2011
- Report Date
- March 14, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECH FOUND THAT THE CENTER ARM SIDE RAIL IS BROKEN AND WILL NOT LATCH. THE TECH REPLACED THE CENTER ARM SIDE RAIL ASSEMBLY TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THAT THE RIGHT HEAD SIDE RAIL WAS BROKE. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTAL CARE BARIATRIC BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |