BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 18102753 · Received November 9, 2023

    Report

    Report Number
    3004553423-2023-02034
    Event Type
    Malfunction
    Date Received
    November 9, 2023
    Date of Event
    October 13, 2023
    Report Date
    November 9, 2023
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K163127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). H10: THE SUSPECT DEVICE HAS NOT BEEN RETURN FOR INVESTIGATION. HOWEVER, VYAIRE TECHNICAL SUPPORT ADVISED THAT THE MAINBOARD NEEDS TO BE REPLACED. FURTHERMORE, NO ROOT CAUSE HAS BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: VYAIRE MEDICAL FIELD SERVICE REPRESENTATIVE (FSR) WENT ON SITE TO CHECK AND INSPECT THE DEVICE. HOWEVER, THE EXACT ROOT CAUSE FOR THIS CASE IS NOT DETERMINABLE. TREND REPORT FAILURE STATED THAT IT CAN BE TRACED TO EPC MALFUNCTION ISSUES RESULTING FROM CRACKS IN THE DIE DUE TO MECHANICAL STRESS CAUSED BY PARTICLES IN THE CONDUCTIVE PASTE AND VARIOUS TOLERANCES OF THE HEAT STACK. THE CONDUCTIVE THERMAL PASTE IS CERAMIC BASED AND THESE PARTICLES WHEN SUBJECTED TO HIGH TEMPERATURES CAN LEAD TO UNEVEN PRESSURE DISTRIBUTION ACROSS THE DIE AND MAY CREATE STRESS POINTS BY THE HEAT SINK (IN COMBINATION WITH THE CERAMIC PARTICLES) THAT CAN RESULT IN CRACKS ON THE EPC DIE AND ITS INTERIOR. THESE CRACKS CAN CAUSE INTERNAL OPEN OR SHORT CIRCUITS LEADING TO DISPLAY ERRORS SUCH AS BLACK/BLANK SCREEN DURING STARTUP, BLUE SCREEN, UI FAILSAFE SCREEN TRIGGERED (CAUSED BY A RESTART OF THE EPC), BIOS PASSWORD SCREEN TRIGGERED, SCRAMBLED SCREEN, OR FROZEN SCREEN DURING OPERATION. AS A RESOLUTION, VYAIRE FSR WENT SITE TO REPLACE MAIN ELECTRONICS FOR BLUE SCREEN ISSUE. REPLACED MAIN ELECTRONICS SUCCESSFULLY. RECONFIGURED MAIN ELECTRONICS. RAN CALIBRATIONS AND VERIFICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BELLAVISTA1000 US VENTILATOR HAD BLUE SCREEN SEEN ON THE DEVICE IN STANDBY. ISSUE HAPPENED PRIOR PATIENT USE, WHILE END USER IS PREPARING THE DEVICE FOR USE. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74718 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL BELLAVISTA 1000 US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown