FDA Adverse Event
Injury
Summary report: N
TOTALCARE BED
MDR report key: 2981114
·
Received February 21, 2013
Report
- Report Number
- 1824206-2013-01049
- Event Type
- Injury
- Date Received
- February 21, 2013
- Date of Event
- February 2, 2013
- Report Date
- February 5, 2013
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM INVESTIGATION INDICATED ALL SIDERAILS ALONG WITH THE ENTIRE BED WAS CHECKED. NO ISSUES OR MALFUNCTIONS WERE FOUND.
Description of Event or Problem · 1
ACCOUNT ALLEGED A PATIENT FELL OUT OF THE BED. ACCOUNT DID NOT GIVE A CLEAR DESCRIPTION OF WHAT HAPPENED WHEN THE ALLEGED INCIDENT OCCURRED. ACCOUNT ONLY STATED THAT PATIENT FELL AND BROKE HER HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 75048 | TOTALCARE BED | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Other |