SKIL-CARE

Description of Event or Problem

NURSING HOME RESIDENT WAS RESTRAINED IN INVACARE WHEELCHAIR WITH A SKIL-CARE SHOULDER STRAP PONCHO RESTRAINT. SHE WAS FOUND HAVING SLID OUT OF THE FRONT OF THE CHAIR WITH HER HEAD RESTING NEAR THE FRONT OF THE SEAT. THE RESTRAINT WAS BUNCHED UP NEAR HER NECK AND UPPER TORSO. THE RESTRAINT WAS IMMEDIATELY REMOVED BECAUSE IT HAD ONLY BEEN 10-15 MINUTES SINCE SHE WAS LAST CHECKED ON. THE CAUSE OF DEATH WAS NOT KNOWN TO US UNTIL THE CORONER'S REPORT WAS RECEIVED ON 10/6/92. THE CORONER RULED THAT THE CAUSE OF DEATH WAS HANGING, ACIDENTIALDEVICE 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, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN, OTHER. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.