FDA Adverse Event
Death
Summary report: N
AM PLUS BED
MDR report key: 371234
·
Received January 11, 2002
Report
- Report Number
- 371234
- Event Type
- Death
- Date Received
- January 11, 2002
- Date of Event
- January 3, 2002
- Report Date
- January 11, 2002
- Manufacturer
- AMERICAN OF MARTINSVILLE
- Product Code
- FNJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SKILLED NURSING FACILITY RESIDENT DIED. PT WAS FOUND WITH HEAD CAUGHT BETWEEN THE MATTRESS AND SIDERAIL OF BED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AM PLUS BED | HEALTH CARE BED | FNJ | AMERICAN OF MARTINSVILLE | 5888-800 | * | |
| 2 | ONE-HALF RAIL FOR AM PLUS BED | BED RAIL | FNJ | AMERICAN OF MARTINSVILLE | 5888-801 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Death | PT PROTECTOR (MOVEMENT ALARM) |