TABLE, HANA, 110 V

Additional Manufacturer Narrative

AT THE END OF THE PROCEDURE, THE PATIENT WAS LEFT UNATTENDED AND WAS NOT SECURED WITH A SAFETY STRAP. THIS RESULTED IN THE PATIENT FALLING FROM THE TABLE. THE PATIENT HAD A SUBDURAL HEMATOMA AND WAS PLACED UNDER MEDICAL OBSERVATION. THE PATIENT EXPIRED WITHIN 100 HOURS FOLLOWING THE EVENT. AT THIS TIME, IT REMAINS UNCLEAR WHETHER THE FALL CONTRIBUTED TO THE PATIENT'S DEATH. NO ISSUES WITH THE TABLE WERE IDENTIFIED. HENCE THE ROUTE CAUSE OF THE EVENT IS NOTED TO BE USER ERROR AS THERE IS A CLEAR WARNING IN THE IFU INSTRUCTING THAT AN ATTENDANT MUST REMAIN PRESENT UNTIL THE PATIENT HAS BEEN SAFELY TRANSFERRED.

Description of Event or Problem

AT THE MOMENT OF PATIENT TRANSFER - END OF A CASE, PERINEAL POST AND BELT/SAFETY STRAP HAD BEEN REMOVED, BOOTS STILL ATTACHED TO PATIENT. HANA TRANSFER BOARD HAD NOT BEEN PLACED FOR TRANSFER ASSISTANCE. PATIENT WAS LEFT 'UNATTENDED' AND FELL TO THE FLOOR WITH BOOTS STILL ATTACHED. ANESTHESIA TURNED TO DISPOSE OF LMA EQUIPMENT AND PROVIDER SHIFTED TO END OF TABLE TO HELP WITH FEET, STRETCHER WAS PULLED UP TO THE OPPOSITE SIDE OF THE TABLE. PATIENT HAD BEEN IN SCISSOR POSITION FOR DURATION OF CASE.

Description of Event or Problem

AT THE MOMENT OF PATIENT TRANSFER - END OF A CASE, PERINEAL POST AND BELT HAD BEEN REMOVED, BOOTS STILL ATTACHED TO PATIENT. HANA TRANSFER BOARD HAD NOT BEEN PLACED FOR TRANSFER ASSISTANCE. PATIENT WAS LEFT 'UNATTENDED' AND FELL TO THE FLOOR WITH BOOTS STILL ATTACHED. ANESTHESIA TURNED TO DISPOSE OF LMA EQUIPMENT AND PROVIDER SHIFTED TO END OF TABLE TO HELP WITH FEET, STRETCHER WAS PULLED UP TO THE OPPOSITE SIDE OF THE TABLE. PATIENT HAD BEEN IN SCISSOR POSITION FOR DURATION OF CASE.