FDA Adverse Event
Death
Summary report: N
BEDRAILS
MDR report key: 20722
·
Received February 2, 1995
Report
- Report Number
- 20722
- Event Type
- Death
- Date Received
- February 2, 1995
- Date of Event
- January 27, 1995
- Report Date
- February 2, 1995
- Manufacturer
- THILL, INC.
- Product Code
- FNL
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
RESIDENT WAS FOUND BY CNA AND LPN AT 1:15 AM HANGING UPSIDE DOWN BETWEEN BEDRAILS AND MATTRESS/BED WITH HEAD NEAR THE FLOOR, LOWER BODY STILL ON THE BED. VEST RESTRAINT IN PLACE ON BODY AND TIED ON BOTH SIDES OF BED. BODY DIFFICULT TO REMOVE FROM RAILS AS WEDGED INTO SMALL SPACE. BED IN LOW POSITION. NO VITAL SIGNS. CPR NOT ATTEMPTED PER RESIDENT'S ADVANCE DIRECTIVES. DEATH CERTIFICATE LISTED CAUSE OF DEATH AS ASPHYXIA DUE TO PRESSURE ON CHEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BEDRAILS | FULL BEDRAILS | FNL | THILL, INC. | 5100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Death | ELECTRIC BED , VEST RESTRAINT |