Description of Event or Problem · 1
THE RESIDENT INVOLVED IN THIS EVENT HAD A HISTORY OF TIPPING HER WHEELCHAIR OVER FORWARD. AN INVACARE FRONT ANTI-TIPPING DEVICE, (MODEL #'S 1326 AND 2226) WAS ADDED TO HER WHEELCHAIR ON MAY 28, 1993. ON AUGUST 10, 1993 A STAFF PERSON WITNESSED THIS RESIDENT SITTING ON THE FRONT EDGE OF SEAT OF WHEELCHAIR THEN LEANING FORWARD AND TO THE SIDE, TIPPING THE WHEELCHAIR OVER. THE RESIDENT FELL FORWARD HITTING HER HEAD ON THE FLOOR, LANDING ON HER LEFT SIDE WITH THE WHEELCHAIR ON TOP OF HER. SHE WAS SENT TO THE HOSPITAL EMERGENCY ROOM AND RELEASED. FOLLOWING THIS INCIDENT ON THE 10TH, THE RESIDENT BEGAN TO EXPERIENCE A DECLINE IN HER MEDICAL CONDITION AND WAS SENT TO THE EMERGENCY ROOM ON AUGUST 12, 1993, AND RELEASED. ON AUGUST 13TH, 1993, THIS RESIDENT WAS AGAIN TRANSFERRED TO THE HOSPITAL EMERGENCY ROOM WHERE WHE EXPIRED FOLLOWING CARDIAC ARREST.AN AUTOPSY WAS REQUESTED AND PERFORMED ON AUGUST 13, 1993. PRELIMINARY RESULTS OF THE AUTOPSY WERE RECEIVED ON AUGUST 16, 1993. CAUSE OF DEATH: CONTUSION TO THE SKULL WITH SUBGALEAL BLEEDING AND FOCAL INTERCRANIAL BLEEDING WITH CEREBRAL EDEMA. THE WHEELCHAIR WAS EVALUATED BY VISUAL EXAMINATION AND ANTI-TIPPING DEVICES WERE SECURE AND IN PLACE.A PERFORMANCE TEST WAS ALSO PERFORMED ON THE WHEELCHAIR AND THE CHAIR DID TIP OVER WITH CONSIDERABLE EFFORT WHILE SITTING ON THE EDGE OF THE SEAT AND LEANING FORWARD AND TO THE SIDE.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-AUG-93. SERVICE PROVIDED BY: OTHER. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE NOT USED AS LABELED/INDENDED.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, UNANTICIPATED. CONCLUSION: USER ERROR CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.