BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 20428591 · Received October 11, 2024

    Report

    Report Number
    3013421741-2024-00487
    Event Type
    Malfunction
    Date Received
    October 11, 2024
    Date of Event
    September 19, 2024
    Report Date
    October 11, 2024
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K183364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION UPDATE: G6, H2, H3, H6 AND H11. FINDINGS / ROOT CAUSE: MAINBOARD EPC COMMUNICATION FAILURE. INVESTIGATION WILL BE CONTINUED UNDER CAPA-000000994. AS THE FAILURE RATE IS WITHIN THE EXPECTED RANGE AS PER OUR RISK FILES, DECIDED TO CLOSE THIS COMPLAINT. CAPA-000000994 SUMMARY: ACCORDING TO CAPA-000000994, THE REPORTED FAILURE 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. REFER TO CAPA-000000994 FOR CORRECTIVE AND PREVENTIVE ACTIONS.

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). D4: UNIQUE IDENTIFIER (UDI) # - UNABLE TO DETERMINE ENTIRE UDI# AS INFORMATION WAS NOT PROVIDED. H3: 81 OTHER - AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. 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 · 0

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE CUSTOMER WAS ABLE TO PROVIDE LOGFILES FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR HAS A BLACK SCREEN WITH JUST THE BLUE LIGHTS. NO PATIENT INVOLVEMENT. FOUND DURING SETUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344969 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL 301.100.030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown