BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BREAS VIVO 45 LS HOME HEALTH VENTILATOR

    MDR report key: 22717181 · Received August 5, 2025

    Report

    Report Number
    MW5174020
    Event Type
    Injury
    Date Received
    August 5, 2025
    Date of Event
    July 16, 2025
    Report Date
    July 25, 2025
    Manufacturer
    BREAS MEDICAL, INC.
    Product Code
    NOU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    HOME HEALTH CARE PATIENT: DURING ROUTINE MONTHLY EQUIPMENT CHECK, VENTILATOR FAILED TO ALARM WHEN DISCONNECTED FROM TEST LUNG. PRE-USE TESTING PERFORMED AND ALL TESTING PASSED BUT VENTILATOR STILL FAILED TO ALARM WHEN DISCONNECTED FROM TEST LUNG. VENTILATOR MAINTAINED A MEASURED INSPIRATORY PRESSURE DESPITE DISCONNECTION FROM THE TEST LUNG CAUSING THE ALARM NOT TO SOUND. AFFECTED VENTILATOR WAS EXCHANGED WITH A NEW VENTILATOR. PRE-USE TESTING PERFORMED AND PASSED. ALL ALARMS FUNCTIONING APPROPRIATELY. BREAS VENTILATOR. BIOMED SENDING "VENTILATOR" BACK TO COMPANY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1765620 BREAS VIVO 45 LS HOME HEALTH VENTILATOR CONTINUOUS, VENTILATOR, HOME USE NOU BREAS MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male Required Intervention