BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONNEX REPAIR BOM

    MDR report key: 24974228 · Received April 23, 2026

    Report

    Report Number
    1316463-2026-00021
    Event Type
    Death
    Date Received
    April 23, 2026
    Date of Event
    March 26, 2026
    Report Date
    April 23, 2026
    Manufacturer
    WELCH ALLYN INC
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FACILITY BIOMED OBTAINED A SPARE CVSM, ADMITTED A TEST PATIENT AND TRIGGERED THE ALARM. THE BIOMED CONFIRMED THAT AN AUDIBLE ALARM WAS NOT HEARD; HOWEVER, THERE WAS A VISUAL INDICATOR PRESENT ON THE DISPLAY. THE BIOMED THEN CONFIRMED THE USB SOUNDBAR WAS CONNECTED TO THE PC AND THE DEFAULT SHELL OF THE CONNEX CS WAS 1.8.3. THE BIOMED ACCESSED THE TASKBAR AND FOUND THAT THE PC'S DELL AC511 USB SOUNDBAR HAD BEEN MUTED BUT WAS SET TO LEVEL 16. THE VOLUME WAS UNMUTED, AND A SIMULATED ALARM WAS NOW AUDIBLE. THE CUSTOMER REPORTED THAT THE SOUNDBAR IS A USB SOUNDBAR SUPPLIED BY THE HOSPITAL AND BIOMED WORKS WITH CLINICAL TO ADJUST THE VOLUME TO THE APPROPRIATE LEVEL. THE CUSTOMER IS INVESTIGATING WHO MUTED THE SOUNDBAR AND HOW LONG IT WAS MUTED; HOWEVER, AT THIS TIME THEY DO NOT BELIEVE THEY HAVE ANY WAY TO TELL HOW LONG IT WAS MUTED. BAXTER INFORMED THE CUSTOMER THAT THE CONNEX CS APPLICATION AND ITS COMPONENTS DO NOT HAVE THE CAPABILITY TO MUTE ANY PERIPHERALS AND IT SENDS AUDIO TO THE WINDOWS DEFAULT AUDIO DEVICE. THE EXACT CAUSE OF THE PATIENT¿S DEATH WAS NOT PROVIDED. BASED ON THE INSPECTION PERFORMED BY THE CUSTOMER THE CONNEX CS WAS FOUND TO BE FUNCTIONING AS DESIGNED. DURING USE, THE AUDIO OUTPUT ON A THIRD-PARTY DEVICE WAS MUTED, RESULTING IN THE USER NOT RECEIVING AN AUDIBLE ALERT. THE CAUSE OF THE EVENT IS ATTRIBUTED TO USE ERROR INVOLVING A THIRD-PARTY DEVICE WITH MUTED AUDIO, WHICH PREVENTED AN AUDIBLE ALARM. THE DEVICE INSTRUCTIONS FOR USE WARNS USERS: "ENSURE THAT ALL AUDIO CABLES ARE INSTALLED AND CONNECTED AND THAT THE VOLUME SETTINGS ARE NOT SET TOO LOW OR ARE NOT SET TO MUTE AS THESE FACTORS MAY CAUSE YOU TO MISS AUDIBLE ALARMS GENERATED FROM THE CONNEX CENTRAL STATION. MAKE THIS INSPECTION ON A DAILY BASIS. THE BEDSIDE PATIENT MONITOR IS THE PRIMARY ALARMING SOURCE FOR THE PATIENT, AND THE CONNEX CENTRAL STATION IS A BACKUP ALARM SOURCE. THE CENTRAL STATION IS ONLY AS RELIABLE AS ITS NETWORK AND SHOULD BE RELIED ON ONLY AS A BACKUP ALARMING DEVICE." BAXTER INFORMED THE CUSTOMER THAT THE CONNEX CS APPLICATION AND ITS COMPONENTS DO NOT HAVE THE CAPABILITY TO MUTE ANY PERIPHERALS AND IT SENDS AUDIO TO THE WINDOWS DEFAULT AUDIO DEVICE. THERE WAS NO MALFUNCTION OR USE ERROR OF ANY BAXTER DEVICE, HOWEVER THE USE ERROR NOTED ABOVE CONTRIBUTED TO THE THIRD-PARTY DEVICE NOT RELAYING AN AUDIBLE ALARM TO THE SECONDARY ALARM SOURCE. IF ANY ADDITIONAL RELEVANT DETAILS ARE RECEIVED, THE COMPLAINT WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    ON (B)(6) 2026, THE CUSTOMER REPORTED THAT THE ALARM ON THE CONNEX CENTRAL STATION IN THE NURSES¿ STATION WAS NOT WORKING, AND A PATIENT WAS FOUND UNRESPONSIVE. DURING FOLLOW UP IT WAS NOTED THAT SP02 WAS BEING MONITORED ON THE PATIENT. ADDITIONALLY, IT WAS REPORTED BY THE CUSTOMER THAT IT WAS NOTICED THAT A VISUAL INDICATOR ON THE CONNEX CS WAS PRESENT AT THE TIME OF THE EVENT. THE CUSTOMER REPORTED THAT A PATIENT WAS FOUND UNRESPONSIVE, A CODE BLUE WAS INITIATED HOWEVER, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS NOT REPORTED; NOR WAS IT REPORTED IF AN AUTOPSY WAS PERFORMED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035173 CONNEX REPAIR BOM MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX WELCH ALLYN INC CONNEX

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death