Description of Event or Problem · 1
8/29/92, 11:10 A.M.; RESIDENT WAS FOUND LYING ON HER RIGHT SIDE ON THE FLOOR IN FRONT OF HER CHAIR POSITIONED IN THE TLSO. A 1-3/4" LACERATION OF THE FOREHEAD WAS OBSERVED AS WELL AS A 3/4" LACERATION OF HER RIGHT EYEBROW AREA. RESIDENT TRANSFERRED TO HOSPITAL EMERGENCY ROOM FOR TREATMENT. RESIDENT DID NOT LOSE CONSCIOUSNESS. ON INVESTIGATION IT WAS FOUND THAT STAFF USED CHAIR OTHER THAN THE CHAIR RECOMMENDED BY THE OTR AND THE L'NARD RESTORATIVE CONCEPTS REPRESENTATIVE TO POSITION RESIDENT. STAFF WERE SUBSEQUENTLY RE-EDUCATED IN THE USE OF THIS ORTHOTIC DEVICE WITH THIS RESIDENTDEVICE 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: . SERVICE PROVIDED BY: UNKNOWN. 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, OTHER, OTHER. RESULTS OF EVALUATION: FAILURE TO FOLLOW INSTRUCTIONS. CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.