BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA 1000

    MDR report key: 12540834 · Received September 28, 2021

    Report

    Report Number
    3004553423-2021-01213
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Date of Event
    August 31, 2021
    Report Date
    August 31, 2021
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CBK
    UDI-DI
    07640149380019
    PMA / PMN Number
    K163127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. HOWEVER, DURING ANALYSIS OF LOG FILE ANALYSIS TOOL AND SCREENSHOT OF SERVICE SCREEN IT SHOWS 2P CALIBRATION OF THE O2 SENSOR FAILED DUE TO THE LEAKING CHECK VALVE. NO FLOW RECORDED WHEN THE FLOW CONTROLLER SET @2 LMN AND 10MBAR BLOWER PRESSURE. AS A RESOLUTION SENT REQUEST CUSTOMER SERVICE TEAM FOR SHIIPING THE MAIN ELECTRONICS UNDER WARRANTY. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BELLAVISTA 1000 ALARMED 401-INSPIRATION VALVE OR DEVICE LEAKY. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1436756 BELLAVISTA 1000 VENTILATOR, CONTINOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA 1000 07640149380019

    Patients

    Seq Age Sex Outcome Treatment
    1