BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIVO 45 LS

    MDR report key: 16874473 · Received May 5, 2023

    Report

    Report Number
    9617566-2023-00003
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    April 3, 2023
    Report Date
    May 5, 2023
    Manufacturer
    BREAS MEDICAL AB
    Product Code
    NOU
    UDI-DI
    07321822300004
    PMA / PMN Number
    K193586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A TOTAL OF (B)(4) SPO2 SENSORS (MASIMOSET LNCS® DCI® SPO2 ADULT REUSABLE FINGER CLIP SENSOR, REF (B)(4), MASIMO CORPORATION, IRVINE, CA) WERE RETURNED TO BREAS MEDICAL ON APR 6, 2023. A MALFUNCTION OF THIS ACCESSORY WAS REPRODUCED ON APR 12, 2023. THE PROBLEM WAS REPORTED TO THE ACCESSORY MANUFACTURER.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE SPO2 SENSORS WERE WORKING ON WHITE PATIENTS BUT NOT AFRICAN AMERICANS WHEN USED AS AN ACCESSORY TO THE BREAS VIVO 45 LS VENTILATOR. THEY ARE RETURNING THE SENSORS AND CABLES FOR CREDIT AFTER THEY ARE CHECKED OUT BY THE SERVICE TEAM. A TOTAL OF (B)(4) SENSORS WERE RETURNED TO BREAS MEDICAL INC. ON 6 APR 2023. NO DEVICE MALFUNCTION WAS REPORTED FOR THE VIVO 45 LS VENTILATOR. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628448 VIVO 45 LS CONTINUOUS, VENTILATOR, HOME USE NOU BREAS MEDICAL AB 230000 MULTIPLE/UNSPECIFIED 07321822300004

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SPO2 SENSOR