BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCOM ALARM SYSTEM

    MDR report key: 24364005 · Received February 17, 2026

    Report

    Report Number
    MW5183868
    Event Type
    Injury
    Date Received
    February 17, 2026
    Report Date
    February 10, 2026
    Manufacturer
    ASCOM US, INC.
    Product Code
    MSX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423824 ASCOM ALARM SYSTEM SYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITORS MSX ASCOM US, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death