BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIVO 45LS

    MDR report key: 25115870 · Received May 7, 2026

    Report

    Report Number
    9617566-2026-00001
    Event Type
    Death
    Date Received
    May 7, 2026
    Date of Event
    April 4, 2026
    Report Date
    May 7, 2026
    Manufacturer
    BREAS MEDICAL AB
    Product Code
    NOU
    PMA / PMN Number
    K233452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BREAS HAS BEEN UNABLE TO PERFORM AN INVESTIGATION AS THE DEVICE HAS NOT BEEN RETURNED. BREAS HAS MADE ATTEMPTS TO CONTACT THE REPORTER FOR MORE INFORMATION AND TO REQUEST THAT THE DEVICE BE RETURNED FOR INVESTIGATION, BUT THERE HAS BEEN NO RESPONSE FROM THE REPORTER AT THIS TIME.

    Additional Manufacturer Narrative · 0

    BREAS MEDICAL INC HAS REACHED OUT TO THE REPORTER TO REQUEST MORE INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR INVESTIGATION ON THREE SEPARATE OCCASIONS: APRIL 6, 2026, MAY 7, 2026, AND MAY 27, 2026. THERE HAS BEEN NO RESPONSE FROM THE INITIAL REPORTER THEREFORE, BREAS IS UNABLE TO MOVE FORWARD WITH AN INVESTIGATION AT THIS TIME. AS SUCH, THIS WILL BE THE FINAL REPORT AND THE BREAS SERVICE REQUEST WILL BE CLOSED.

    Description of Event or Problem · 0

    ON APRIL 7TH, BREAS MEDICAL RECEIVED INFORMATION THAT A VIVO 45LS - SN NOT REPORTED - WAS INVOLVED IN AN INCIDENT IN THE US. FAULT DESCRIPTION PER REPORTER: "GOOD MORNING, QUICK QUESTION, IS THERE A WAY TO SEE WHAT ALARMS HAVE OCCURED ON A BREAS REMOTELY. I LOOKED THROUGH THE MANUAL AND DIDN'T SEE ANY INFORMATION. I HAVE AN INVASIVE PATIENT THAT PASSED FRIDAY/SATURDAY MORNING DUE TO VENT BEING OFF IS WHAT I WAS TOLD. I HAVE NOT HEARD FROM THE FAMILY AS OF YET. THE MESSAGE WAS A TEXT MESSAGE FROM THE NURSING CAREGIVERS' MANAGER EARLY SATURDAY MORNING."

    Description of Event or Problem · 0

    ON APRIL 7TH, BREAS MEDICAL RECEIVED INFORMATION THAT A VIVO 45LS - SN NOT REPORTED - WAS INVOLVED IN AN INCIDENT IN THE US. FAULT. DESCRIPTION PER REPORTER: "GOOD MORNING, QUICK QUESTION, IS THERE A WAY TO SEE WHAT ALARMS HAVE OCCURED ON A BREAS REMOTELY. I LOOKED THROUGH THE MANUAL AND DIDN'T SEE ANY INFORMATION. I HAVE AN INVASIVE PATIENT THAT PASSED FRIDAY/SATURDAY MORNING DUE TO VENT BEING OFF IS WHAT I WAS TOLD. I HAVE NOT HEARD FROM THE FAMILY AS OF YET, THE MESSAGE WAS A TEXT MESSAGE FROM THE NURSING CAREGIVERS MANAGER EARLY SATURDAY MORNING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599460 VIVO 45LS CONTINUOUS, VENTILATOR, HOME USE NOU BREAS MEDICAL AB 230000

    Patients

    Seq Age Sex Outcome Treatment
    1