Description of Event or Problem · 1
PATIENT SEEN AT 10:15 P.M. ON 1/25/93 IN CRIB-BED, RESTING QUIETLY - BED RAILS UP AT 11:10 P.M. PATIENT FOUND LYING ON FLOOR, RAIL ON WINDOW SIDE OF BED WAS DOWN. NO ONE HAD BEEN IN ROOM PRIOR. HOPITALIZED DWITH FRACTURED RIGHT HIP AND LACERATION TO HEADDEVICE 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-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, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN, OTHER, FAILURE TO FOLLOW INSTRUCTIONS. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, USER EDUCATION PROVIDED, INSERVICED BY BIOMEDICAL ENGINEERING DEPT. STAFF. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.