BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAVISTA

    MDR report key: 11274246 · Received February 3, 2021

    Report

    Report Number
    3004553423-2021-00793
    Event Type
    Injury
    Date Received
    February 3, 2021
    Date of Event
    January 6, 2021
    Report Date
    January 6, 2021
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CBK
    UDI-DI
    07640149388183
    PMA / PMN Number
    K163127
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: VYAIRE MEDICAL DETERMINED ROOT CAUSE AS DUE TO O2 SENSOR LONG-LIFE DEFECTIVE. MECHANICAL DEFORMATION OF A PART INSIDE THE SENSOR MOST LIKELY CAUSED BY EXPOSURE TO TOO HIGH TEMPERATURE DURING TRANSPORTATION. SENSOR SERIAL NUMBER IS INSIDE THE AFFECTED SERIAL NUMBER RANGE. LOGFILE WAS REVIEWED AND ADVISED THE END USER TO PERFORM A 2P CALIBRATION OF THE O2 SENSOR IN THE CALIBRATION ASSIST. TECHNICAL SUPPORT ADDED THAT THIS IS PURELY AN O2 CELL CALIBRATION ISSUE AND HAVE NO IMPACT ON UNIT DOSING.

    Additional Manufacturer Narrative · 1

    A VYAIRE FIELD SERVICE REPRESENTATIVE (FSR) WENT ONSITE AND EVALUATED THE VENTILATOR. THE FSR WAS ABLE TO DUPLICATE THE REPORTED ISSUE. AS A RESOLUTION, O2 (OXYGEN) SENSOR WAS REPLACED. AFTER REPLACEMENT, FSR PERFORMED OVP (OPERATIONAL VERIFICATION PROCEDURE) AND THE VENTILATOR PASSED ALL TEST PER BELLAVISTA SERVICE MANUAL. NO ROOT CAUSE HAS BEEN DETERMINED AT THIS TIME, SINCE THE INVESTIGATION IS STILL ONGOING. 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 TO VYAIRE MEDICAL THAT THE BELLAVISTA 1000 US VENTILATOR ALARMED O2 (OXYGEN) CALIBRATION NEEDED AND THE SCREEN TURNED BLANK AND RED WHERE THE FIO2 (FRACTION OF INSPIRED OXYGEN) IS DISPLAYED. THERE WAS NO OXYGEN BEING DELIVERED AND WOULD NOT LET THE END USER CALIBRATE OR CHANGE OUT OF THE HUMIDIFIED HIGH FLOW (HHF) SCREEN. THE ISSUE OCCURRED DURING PATIENT USE AND LEAD TO DESATURATION, THE PATIENT WAS PLACED ON A NON-REBREATHER (NRB). NO OTHER ISSUES NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170488 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA 1000 US 07640149388183

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention