FDA Adverse Event
Death
Summary report: N
HOSPITAL BED MANUAL
MDR report key: 501486
·
Received December 2, 2003
Report
- Report Number
- 2182305-2003-00006
- Event Type
- Death
- Date Received
- December 2, 2003
- Date of Event
- October 13, 2003
- Report Date
- December 1, 2003
- Manufacturer
- SUNRISE MEDICAL
- Product Code
- FNL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
RESIDENT WAS FOUND DECEASED IN ROOM. "PER LIABILITY CARRIER THEIR INVESTIGATION INDICATES RESIDENT'S BODY WENT BETWEEN THE BED MATTRESS AND BED RAIL, WITH THE BED RAIL RESTING AGAINST NECK." NO IDENTIFICATION AS TO THE MAKE AND MODEL OF THE RAIL COMBINATION, ALSO NO MATTRESS MAKE, MODEL, OR DIMENSIONS WERE MENTIONED. BED WAS IDENTIFIED AS THE EZC SERIES, HI/LOW MODEL B732 BELIEVED TO BE MANUFACTURED BY SUNRISE MEDICAL. NO OTHER INFO IS KNOWN AT THIS TIME ABOUT INCIDENT OR RESIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOSPITAL BED MANUAL | BED MANUAL | FNL | SUNRISE MEDICAL | B732 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Death |