FDA Adverse Event Death Summary report: N

*

MDR report key: 514117 · Received January 20, 2004

Report

Report Number
MW4003685
Event Type
Death
Date Received
January 20, 2004
Manufacturer
UNK
Product Code
FNJ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
KS, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

CORONER'S REPORT STATES THAT PT SUFFERED AN ACCIDENTAL DEATH DUE TO ASPHYXIATION FROM NECK BEING CAUGHT IN A BED RAIL. THE TIME OF DEATH IS SHOWN AS UNK, BECAUSE NO ONE WAS SURE WHEN PT WAS LAST SEEN ALIVE; PT WAS FOUND DEAD AT ABOUT 3:40 P.M. PT DID NOT HAVE A PHYSICIAN'S ORDER FOR BED RAILS. ACCORDING TO FEDERAL REGULATIONS, PHYSICAL RESTRAINTS MUST BE USED ONLY TO TREAT MEDICAL SYMPTOMS AND ONLY AFTER A COMPREHENSIVE ASSESSMENT INDICATING THAT THE DEVICE IS THE LEAST RESTRICTIVE INTERVENTION AND THAT IT PROMOTES THE RESIDENT'S HIGHEST LEVEL OF FUNCTION. ITS USE MUST BE MONITORED FOR ADVERSE EFFECTS AND ONGOING ATTEMPTS MUST BE MADE TO FIND LESS RESTRICTIVE ALTERNATIVES. THIS WAS NOT DONE FOR PT. PT WAS FOUND WEDGED BETWEEN AN INAPPROPRIATELY FITTING AIR MATTRESS AND THE BED RAIL. THE BOTTOM PORTION OF THE BED RAIL WAS PRESSED FIRMLY AGAINST PT'S NECK. PT WAS PHYSICALLY UNABLE TO FREE SELF AND THE BED RAIL PRESSED AGAINST THEIR WINDPIPE, PREVENTING THEM FROM CALLING OUT FOR HELP. THE CORONER TOLD REPORTER THAT IT PROBABLY TOOK ABOUT FIVE MINUTES TO DIE FROM LACK OF OXYGEN. FACILITY USED THE BED RAILS FOR THE SOLE PURPOSE OF PREVENTING PT'S MOVEMENT OUT OF BED. PT HAD EXPERIENCED TWO STROKES, AND DUE TO EXTREME WEAKNESS IN EXTREMITIES, COULD NOT USE THE BED RAILS TO ASSIST WITH MOVEMENT IN AND OUT OF BED. THE BED RAILS WERE ONLY BEING USED AS A FORM OF RESTRAINT AND TO PREVENT PT FROM LEAVING THE BED. PT COULD NOT REMOVE THE BED RAILS NOR COULD THEY RAISE OR LOWER THEM. FACILITY FAILED TO USE ALTERNATIVES TO BED RAILS, SUCH AS: PLACING THE BED LOWER TO THE FLOOR AND SURROUNDING THE BED WITH A SOFT MAT, PROVIDING FREQUENT STAFF MONITORING, OR ANY OTHER LESS RESTRICTIVE INTERVENTIONS. ALSO FAILED TO EXPLAIN THE POSITIVE AND NEGATIVE OUTCOMES OF RESTRAINT USE AND TO PROVIDE EDUCATION REGARDING RESTRAINT REDUCTION. REPORTER HAD POWER-OF-ATTORNEY FOR PT AND NO ONE EVER SPOKE WITH THEM ABOUT RESTRAINT OR BED RAIL USE. IN FACT, REPORTER SPOKE WITH THREE CHARGE NURSES AND THE DIRECTOR OF NURSING ABOUT CONCERNS ABOUT THE BED RAILS (AS RECENT AS THREE DAYS BEFORE PT'S DEATH). FACILITY TOOK NO ACTION IN PT'S BEHALF NOR WERE REPORTER'S CONCERNS AND DISMAYS ADDRESSED. HOWEVER, AFTER PT'S DEATH, THEY HAVE SINCE REMOVED OTHER RESIDENTS' BED RAILS AND HAVE OBTAINED DIFFERENT TYPES OF BEDS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 * BEDRAIL FNJ UNK * *

Patients

Seq Age Sex Outcome Treatment
1 80 YR Death