Description of Event or Problem · 1
THE RESIDENT FELL OUT OF BED. IF THE SIDERAILS WERE UP IN THE CORRECT POSITION AS STATED BY NURSING PERSONNEL, THEN THE SIDERAIL MUST HAVE FALLEN PREMATURELY WHILE UNATTENDED, SINCE THERE IS A CONCENSUS THAT THE RESIDENT IS TOO WEAK TO CLIMB OVER THE SIDERAILS. SEE ATTACHED SUPPLEMENT FOR DEVICE EVALUATION. THE RESIDENT WAS TREATED FOR A LACERATION TO THE LEFT TEMPORAL AREA OF THE HEAD. LATER, A CT SCAN REVEALED A "TRAUMA TO THE LEFT BRAIN SURFACE", AS REPORTED BY THE FAMILY. THE RESIDENT STILL REMAINS IN THE ACUTE FACILITY AT THIS TIMEDEVICE NOT LABELED FOR SINGLE USE. 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: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN - INADEQUATE, INADEQUATE QUALITY ASSURANCE, INVALID DATA. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED, INSERVICED BY OTHER FACILITY STAFF, NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.