BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 14138179 · Received April 18, 2022

    Report

    Report Number
    3004553423-2022-01492
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    March 21, 2022
    Report Date
    March 21, 2022
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CBK
    UDI-DI
    07640149388183
    PMA / PMN Number
    K163127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE FILE IDENTIFICATION: (B)(4). THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. INFORMED CUSTOMER THAT THE PLV ALARM ESSENTIALLY MEANS THAT THE SETTING NEED TO BE ADJUSTED AND THAT IT IS NORMAL IN VOLUME BASED VENTILATION MODES. RESULTS OF INVESTIGATION: THE ROOT CAUSE WAS DETERMINED DUE TO USER FAULT - USER FAULT - OTHERS. LACK OF TRAINING / UNDERSTANDING OF THE BELLAVISTA PLV (PRESSURE LIMITED VENTILATION) LUNG PROTECTION SAFETY FEATURE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED BELLAVISTA1000 US HAVING LOW TIDAL VOLUME ISSUE, NOT DELIVERING ENOUGH VOLUME SKIMMED THROUGH LOGS AND SAW THAT PLV IS BEING ACTIVATED. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658001 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA 1000 US 07640149388183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown