UNIVERSAL

Description of Event or Problem

PATIENT WAS FOUND ON THE FLOOR OF HIS ROOM, IN HIS WHEELCHAIR. HE WAS RESTRAINED, RESTRAINT WAS STILLL INTACT, WHEELCHAIR WAS ON IT'S SIDE, AS WAS PATIENT. PATIENT SUSTAINED A FRACTURED SKULL. PATIENT WAS TRANSFERRED TO ROCKVILLE GENERAL HOSPITAL AND DIED SEVEN DAYS LATER.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.