FDA Adverse Event
Other
Summary report: N
SIMMONS MULTIMATE BED
MDR report key: 35666
·
Received July 12, 1996
Report
- Report Number
- 35666
- Event Type
- Other
- Date Received
- July 12, 1996
- Date of Event
- March 29, 1996
- Report Date
- April 2, 1996
- Manufacturer
- SIMMONS HEALTHCARE CORP.
- Product Code
- FNJ
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT WAS FOUND ON FLOOR TO LEFT OF BED. LACERATION PRESENT AT RIGHT EYEBROW AREA. LEFT SIDE RAIL WAS DOWN. STAFF CANNOT ASCERTAIN THAT BED RAIL WAS IN THE UP POSITION JUST PRIOR TO THE FALL. UPON INSPECTION, THE LOCK ROD SPRING AND KNOB ASSEMBLY WAS INSTALLED INCORRECTLY WITH THE KNOB TOWARD THE INSIDE OF THE SIDE RAIL. THIS RESULTED IN A FALSE LOCK CONDITION, IF THE RAIL WAS RAISED GENTLY UNTIL A "CLICK" WAS HEARD. IN THE FALSE LOCK CONDITION, PRESSURE TO THE TOP OF THE RAIL CAUSED THE RAIL TO DROP DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIMMONS MULTIMATE BED | BED | FNJ | SIMMONS HEALTHCARE CORP. | 3.1 L-531-362 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 95 YR | Other |