VEST RESTRAINT

Description of Event or Problem

THE DECEDENT WAS A LONG TERM PATIENT AT FAIR ACRES WHO REPORTEDLY SLIPPED OUT OF HER RESTRAINTS AND WAS FOUND IN A HANGING POSITION WITH THE RESTRAINT FORMING A LIGATURE AROUND THE NECK. THE DECEDENT IS REPORTED TO HAVE A HISTORY OF HUNTINGTON'S CHOREA WITH DEMENTIA. SIMILAR DEVICES WERE BEING USED AT THIS TIMEDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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, A DEVICE FROM SAME LOT WAS EVALUATED. RESULTS OF EVALUATION: OTHER. CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION, THERE WAS NO DEVICE FAILURE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.