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Patient 1
THE PATIENT WAS RIDING THE WHEELCHAIR DOWN THE HALLWAY WHEN THE BALLBEARING GAVE WAY AND THE LEFT FRONT SMALL WHEEL FELL OFF OF THE WHEELCHAIR. THE WHEELCHAIR TIPPED FORWARD AND THE PATIENT FELL OUT OF THE WHEELCHAIR. THE PATIENT HIT HER LEFT ARM ON THE FLOOR. THE PATIENT SUFFERED A LEFT PROXIMAL HUMERUS FRACTURE. THE PATIENT WAS FOLLOWED UP BY AN APPOINTMENT WITH A LOCAL ORTHOPEDIC SURGEON AND A SLING TO IMMOBILIZE THE SHOULDER AND ARM. THE COMPANY IS OUT OF BUSINESS. THE WHEELCHAIR WAS DONATEDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-NOV-92. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.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, VISUAL EXAMINATION. RESULTS OF EVALUATION: MATERIAL DEGRADATION/DETERIORATION. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.