BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAS VIVO 45 LS

    MDR report key: 22771386 · Received August 11, 2025

    Report

    Report Number
    MW5174303
    Event Type
    Injury
    Date Received
    August 11, 2025
    Date of Event
    June 18, 2025
    Report Date
    August 5, 2025
    Manufacturer
    BREAS MEDICAL, INC.
    Product Code
    NOU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BREAS VENTILATOR BEING USED IN PATIENT HOME. THERAPIST REPORTED THE VENTILATOR WAS NOT PRODUCING A DISCONNECTION ALARM WHEN THEY VISIBLY NOTICED THAT THE PATIENT WAS DISCONNECTED FROM THE VENTILATOR. WHEN THERAPIST ARRIVED AT THE HOME SHE DISCONNECTED THE PATIENT FROM THE VENT AND FOUND THE VENT DID NOT ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2271009 BREAS VIVO 45 LS CONTINUOUS, VENTILATOR, HOME USE NOU BREAS MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female Required Intervention