FDA Adverse Event
Other
Summary report: N
ELITE RISER
MDR report key: 3688127
·
Received February 26, 2014
Report
- Report Number
- 1931947-2014-00001
- Event Type
- Other
- Date Received
- February 26, 2014
- Date of Event
- February 7, 2014
- Report Date
- February 26, 2014
- Manufacturer
- NOA MEDICAL INDUSTRIES, INC.
- Product Code
- FNL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
NO PRIOR HISTORY OF SIMILAR COMPLAINT SINCE MARKET INTRODUCTION FIVE YEARS AGO. TRENDING FOR SIMILAR COMPLAINTS IN THE FUTURE IS BEING PERFORMED. THERE IS NO FURTHER CORRECTIVE ACTION PLANNED AT THIS TIME.
Description of Event or Problem · 1
RESIDENT WAS SITTING IN WHEEL CHAIR FACING THE BED. SHE GRABBED THE ASSIST BAR TO PULL HERSELF UP WHEN THE HEAD OF THE BED ROSE AND SHE FELL BACK AWAY FROM THE BED. THE HEAD OF THE BED WAS SLIGHTLY ELEVATED WHEN SHE GRABBED THE ASSIST BAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 119336 | ELITE RISER | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | NOA MEDICAL INDUSTRIES, INC. | 1050010BEI-T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other |