FDA Adverse Event Death Summary report: N

POSEY GERIATRIC CHAIR-Y-SAFETY BELT

MDR report key: 797 · Received June 26, 1992

Report

Report Number
797
Event Type
Death
Date Received
June 26, 1992
Date of Event
March 22, 1992
Report Date
June 18, 1992
Manufacturer
J.T. POSEY COMPANY
Product Code
FMQ
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

RESTRAINT DEVICE WAS APPLIED TO RESIDENT WHILE IN A GERICHAIR (DEVICE DESIGNED FOR THIS PURPOSE) BECAUSE RESIDENT HAD DEVELOPED A HISTORY OF SLIPPING DOWN WHILE IN THE GERICHAIR AND THERE WAS CONCERN THAT HER NECK WOULD BE CAUGHT ON THE TABLE TOP OF THE GERICHAIR. WHILE SECURED IN THIS DEVICE ON MARCH 22, 1992, RESIDENT APPARENTLY MANAGED TO SLIDE DOWN IN THE GERICHAIR WITH THE RESTRAINT APPLIED AND WAS STRANGLED BY THE CROSS MEMBER TO WHICH THE SHOULDER STRAPS ARE JOINED BELOWED THE NECKLINE. PATIENT WAS OBSERVED AT APPROXIMATELY 2:38 P.M. BY A CHARGE NURSE AND WAS UPRIGHT IN HER CHAIR WITH NO SIGNS OF ANY DISTRESS. AT APPROXIMATELY 2:45 P.M., A CNA OBSERVED THE RESIDENT APPARENTLY CHOKING AND IN SUBSTANTIAL DISTRESS. PATIENT WAS IMMEDIATELY TAKEN TO A NURSES STATION (40 FEET AWAY) AND WAS RELEASED FROM THE CHAIR BY A LPN AND AN RN. MOUTH TO MOUTH RESUSCITATION WAS IMMEDIATELY BEGUN AND ADDITIONAL ASSISTANCE WAS GIVEN THROUGH USE OF AN AMBU BAG. PATIENT WAS RESUSCITATED AND IMMEDIATELY TRANSPORTED TO THE NEAREST HOSPITAL AND, AFTER BEING ATTENDED TO IN THE EMERGENCY ROOM, WAS TRANSFERRED DTO A REGULAR PATIENT ROOM. PATIENT EXPIRED IN THE HOSPITAL APPROXIMATELY 17 HOURS AFTER BEING ADMITTED INTO THE EMERGENCY ROOM. THGE FINAL SUMMARY OF THE CORONER'S REPORT DATED MARCH 26, 1992, STATES "---THE CAUSE OF DEATH APPEARS TO BE FROM MECHANICAL COMPRESSION OF NECK BY THE POSEY RESTRAINT. THE MANNER OF DEATH IS CLASSIFIABLE AS ACCIDENTAL.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN, NONE OR UNKNOWN, NONE OR UNKNOWN. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, USE OF ALL SIMILAR DEVICES STOPPED PERMANENTLY. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 POSEY GERIATRIC CHAIR-Y-SAFETY BELT GERICHAIR RESTRAINT FMQ J.T. POSEY COMPANY 5163-4110 UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 78 YR Death