BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIVO 45LS

    MDR report key: 21561948 · Received March 10, 2025

    Report

    Report Number
    9617566-2025-00002
    Event Type
    Death
    Date Received
    March 10, 2025
    Date of Event
    October 11, 2024
    Report Date
    January 30, 2025
    Manufacturer
    BREAS MEDICAL AB
    Product Code
    CBK
    PMA / PMN Number
    K193586
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    JANUARY 9, 2025: BREAS MEDICAL RECEIVED A CUSTOMER REPORT THAT A PATIENT HAD EXPIRED WHILE USING A BREAS VIVO 45LS. THIS WAS PROVIDED BY THE CUSTOMER ROTECH INC.: 'THIS PT DAUGHTER SENT US A TEXT STATING THE MOM PASSED AWAY AND STATED THE MACHINE PLAYED A FACTOR IN HER DEATH I HAVE BEEN TRYING TO GET THIS SENT OFF AND I HAVE NOT HEARD ANYTHING FROM THE FAMILY SINCE THIS DATE ' BREAS RECEIVED THE DEVICE ON JANUARY 16, 2025. THE INVESTIGATION IS ONGOING. LOG FILES HAVE BEEN REVIEWED BUT THERE IS NO DATA IN THE FILES FROM THE REPORTED DATE OF THE EVENT. NOTHING IN THE LOG FILES INDICATES THAT THE VENTILATOR STOPPED WORKING. BREAS REACHED OUT TO THE CUSTOMER VIA EMAIL ON JANUARY 27, 2025 TO REQUEST MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451178 VIVO 45LS VENTILATOR CBK BREAS MEDICAL AB 230000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Death