BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAVISTA

    MDR report key: 12694361 · Received October 25, 2021

    Report

    Report Number
    3004553423-2021-01246
    Event Type
    Injury
    Date Received
    October 25, 2021
    Date of Event
    September 27, 2021
    Report Date
    September 27, 2021
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CKB
    UDI-DI
    07640149380026
    PMA / PMN Number
    K163127
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION UPDATE: RESULTS OF INVESTIGATION: VYAIRE MEDICAL WAS ABLE TO CONFIRM THE ISSUE, AND ALARM 305 WAS RESOLVED AFTER A RESTART. THE HL7 PROTOCOL WAS CONFIRMED TO BE ENABLED. ROOT CAUSE OF FAILURE WAS DETERMINED DUE TO THE COMMUNICATION BETWEEN THE USER INTERFACE CONTROLLER (EPC) AND THE VENTILATION CONTROLLER (CFB) WAS DISRUPTED AND WAS ONLY RE-ESTABLISHED AFTER THE MACHINE WAS RESTARTED. THE VENTILATION CONTROLLER SOFTWARE STOPS DUE TO A CONFLICT IN MEMORY RESOURCE ALLOCATION BETWEEN SOFTWARE TASKS, RESULTING IN THE GENERATION OF THE TECHNICAL FAILURE ALARM 305. A COMBINATION OF SOFTWARE VERSION 6.0.1600.0 OR HIGHER AND ACTIVE HL7 DATA TRANSMISSION IS REQUIRED FOR THE FAILURE CONDITION. THE SOFTWARE PATCH V6.0.2100.0 IS CURRENTLY BEING DEVELOPED. CAPA: I-CH-21-018 / CAPA-000000906 / FSCA 2021-001 TRIGGERED. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. CORRECTED DATA: D2 CHANGE PROCODE FROM CKB TO CBK.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. HOWEVER, LOG FILES WERE PROVIDED. NO ROOT CAUSE HAS BEEN DETERMINED YET BECAUSE THE INVESTIGATION IS STILL ON GOING. THIS COMPLAINT IS CASE LINK WITH (B)(4) WITH SERIAL NUMBER (B)(4), THAT HAS PATIENT INVOLVEMENT. 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 1000E WAS HAVING A TECHNICAL FAILURE ALARM 305 COMMUNICATION TO CFB DISCONNECTED MESSAGE WITH A RED ALERT: SCREEN FREEZES AND BREATHING STOPS WHILE CONNECTED TO A PATIENT WITH NO SERIOUS CONSEQUENCES. THE PATIENT WAS BAGGED MANUALLY UNTIL THE NEW VENTILATOR WAS READY. DUE TO THE SAME ERROR, FIVE DEVICES ARE CURRENTLY UNABLE TO OPERATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1589920 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CKB IMTMEDICAL AG BELLAVISTA 1000E 07640149380026

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention