D
Patient 1
PATIENT DISCOVERED HANGING OVER BEDSIDE RAIL WITH POSEY RESTRAINT STILL ON. ONE RESTRAINT STRAP LOOSE. HANGING WITH HEAD ABOUT ONE TO TWO INCCHES FROM FLOOR. BLOOD WAS RESTRAINT AT NECK LINE, AND AROUND MOUTH WAS FOUND AT 5:45 A.M. BY CNA. WAS SENT TO MEDICAL CENTER FOR EVALUATION. DIED IN HOSPITAL SEVERAL HOURS LATER. STATE SURVEYOR REPORTED ON HIS HOSPITAL RECORD 1. POSSIBLE MULTIPLE INTERNAL INJURIES. 2. SHOCK, PROBABLY SECONDARY TO RESTRAINT. 3. CARDIAC ARRESTINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED, INSERVICED BY MANUFACTURER/DISTRIBUTOR REPRESENTATIVE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.