ASCOM ALARM SYSTEM

Description of Event or Problem

THIS LETTER IS TO INFORM YOU THAT (B)(6) HEALTHCARE ((B)(6)) WAS INFORMED ON (B)(6) 2026 BY HOPITAL (B)(6) IN (B)(6) REPORTING THAT A PATIENT DEATH OCCURRED AND THE ASCOM SECONDARY ALARM NOTIFICATION SYSTEM DID NOT ALARM AS THE USERS EXPECTED. THE PATIENT WAS BEING MONITORED ON A (B)(6) TELEMETRY MONITORING SYSTEM AND CSCS V3 CENTRAL STATION. THE CUSTOMER CLARIFIED THAT THE (B)(6) DEVICES ASSERTED THE EXPECTED ALARMS APPROPRIATELY AND DID NOT ALLEGE ANY DEFICIENCY OF THE (B)(6) DEVICES. (B)(6) SERVICE PERSONNEL VISITED THE CUSTOMER SITE, TESTED THE (B)(6) DEVICES WITH A SIMULATOR, AND CONFIRMED THAT THEY WERE OPERATING AND ALARMING AS SPECIFIED. (B)(6) CONCLUDED THAT THERE WAS NO INDICATION OF A (B)(6) DEVICE MALFUNCTION AND THAT THE (B)(6) DEVICES DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT¿S DEMISE. THE CUSTOMER ALSO ENGAGED ASCOM TO INVESTIGATE. THE ASCOM SECONDARY ALARM NOTIFICATION SYSTEM IS NOT MANUFACTURED BY (B)(6). THE ASCOM SYSTEM IS MANUFACTURED BY ASCOM, WHO¿S AMERICAN OPERATIONS ARE IN (B)(6). (B)(6) NOTIFIED ASCOM OF THE EVENT ON (B)(6) 2026. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).