Description of Event or Problem · 1
AT APPROXIMATELY 6:00 A.M. ON 1/1/92, WHEN STAFF BEGAN MAKING THEIR MORNING ROUNDS A PATIENT WAS FOUND BY NURSE AIDE WITH HER NECK CAUGHT BETWEEN THE 2ND AND 3RD RING OF THE SIDE RAIL. PATIENT WAS FREED FROM THE BED RAIL, AND LVN CHECKED HER FOR VITAL SIGNS. NONE WERE PRESENT. SHE WAS PRONOUNCED DEAD BY DON-RN, AND THE BODY WAS REMOVED FROM THE NURSING HOME. AN AUTOPSY WAS PERFORMED BY DR. AND THE INTERNAL INVESTIGATION, INVESTIGATIONS BY THE TEXAS DEPARTMENT OF HEALTH, TEXAS ATTORNEY GENERAL'S OFFICE, AND THE AUSTIN POLICE DEPARTMENT ARE ONGOINGDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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: MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION, NONE OR UNKNOWN, OTHER. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS, USER EDUCATION PROVIDED, INSERVICED BY OTHER FACILITY STAFF. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.