THD EVOLUTION US

Description of Event or Problem

THE PATIENT WAS ANESTHETIZED AND PREPARED FOR THD PROCEDURE. WHEN EVERYTHING WAS READY, THE GENERATOR HAS BEEN SWITCHED ON, THE SCREEN WAS BLUE BUT NO WORDS APPEARED ON IT AND IT WAS NOT POSSIBLE TO START THE CASE. THEY TRIED TO TURN IT ON AGAIN BUT THEY HAD THE SAME PROBLEM. WHILE WAITING THAT THE SPECIALIST ARRIVED IN THE HOSPITAL WITH ANOTHER GENERATOR, THE ANESTHESIOLOGIST WOKE UP THE PATIENT. THEY PUT THE PATIENT BACK UNDER WHEN THE SPECIALIST DELIVERED THE SECOND GENERATOR. THE PATIENT RECEIVED ANESTHESIA TWICE IN ONE DAY. THE DELAY WAS ABOUT 45 MINUTES. THE CASE WENT WELL AND THE PATIENT TOLERATED THE PROCEDURE WITHOUT FURTHER INCIDENT.

Additional Manufacturer Narrative

WHEN THE DEVICE ARRIVED AT THD INC. HEADQUARTERS, IT HAS BEEN FOUND THAT THE CASE WAS DAMAGED. FURTHERMORE, ALWAYS IN THD INC. SITE, THE DEVICE HAS BEEN SWITCHED ON (BY PERSONNEL UNSKILLED IN THE PROCESS) BY FOLLOWING THE INSTRUCTIONS REPORTED IN THE USER MANUAL (REF. (B)(4)): THE DISPLAY SWITCHED ON WITHOUT SHOWING ANY CHARACTER. WE ARE WAITING TO RECEIVE THE DEVICE AT THE HEADQUATER OF THD SPA (ITALY), IN ORDER TO COMPLETE THE INVESTIGATION (THE DEVICE IS WAITING FOR CLEARANCE AT THE CUSTOMS).