BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVO VENTILATOR

    MDR report key: 22461109 · Received July 9, 2025

    Report

    Report Number
    MW5172469
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    July 4, 2025
    Report Date
    July 5, 2025
    Manufacturer
    BREAS MEDICAL, INC.
    Product Code
    NOU
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE WERE AT A FRIEND'S HOUSE YESTERDAY FOR THE 4TH OF JULY, AND OUR SON'S VIVO VENT SEEMS TO HAVE OVERHEATED. HERE ARE THE ALARMS: 12:54PM; PRESSURE COMP LOST; TEMPERATURE COMP LOST; HUMIDITY COMP LOST; AIR TEMP SENSOR FAIL 12:57PM. CLICK-IN BATTERY DISCONNECTED. POWER SOURCE: CLICK-IN BATTERY. INTERNAL BATTERY; POWER FAIL; TREATMENT STOP. WE SWAPPED HIM TO OUR BACKUP VENT, WHICH HAD BEEN IN OUR CAR (HOTTER THAN OUTSIDE), AND WE PUT THIS ONE INSIDE THE HOUSE. WE LEFT OUR FRIEND'S HOUSE 4 HOURS LATER WITH NO OTHER ISSUES, AND WE WERE ABLE TO SWITCH BACK TO OUR PRIMARY VENT AT HOME. HOWEVER, THE PRESTART CHECKS FAILED FOR BOTH VENTS. WE HAD ARRIVED AT THEIR HOUSE AROUND AN HOUR BEFORE THE ISSUE. WE HAVE ONLY BEEN ON THE VIVO FOR JUST A FEW WEEKS, SO WE DON'T HAVE A LOT OF EXPERIENCE WITH IT. WE NEVER HAD THIS ISSUE WITH 2.5 YEARS ON THE TRILOGY EVO. IT IS FREQUENTLY HOT HERE (HIGHS IN THE SUMMER EXCEED 110 DEGREES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279250 VIVO VENTILATOR CONTINUOUS, VENTILATOR, HOME USE NOU BREAS MEDICAL, INC. 45LS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown