FDA Adverse Event
Injury
Summary report: N
TOTALCARE BARIATRIC PLUS
MDR report key: 2618107
·
Received June 7, 2012
Report
- Report Number
- 1824206-2012-03273
- Event Type
- Injury
- Date Received
- June 7, 2012
- Date of Event
- May 19, 2012
- Report Date
- May 23, 2012
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN PERFORMED A BED FUNCTION CHECK AND FOUND IT TO BE WORKING AS DESIGNED.
Description of Event or Problem · 1
A NURSE ASSISTANT WAS ASSISTING WITH TURNING THE PT; THE PT ROLLED TOO FAR AND FELL OUT OF THE BED OVER TOP OF THE SIDERAIL. AN X-RAY WAS TAKEN OF THE PTS SHOULDER WHICH IDENTIFIED A FRACTURED HUMOROUS. THE PTS SHOULDER WAS IMMOBILIZED AND PAIN MANAGEMENT ADMINISTERED. ACCOUNT STATED THAT ROTATION AND TURN ASSIST FUNCTIONS WERE NOT BEING USED AT THE TIME OF THE EVENT. THE ACCOUNT INDICATED THAT THE BED WAS NOT AT FAULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE BARIATRIC PLUS | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |