BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAVISTA

    MDR report key: 12137478 · Received July 8, 2021

    Report

    Report Number
    3004553423-2021-01093
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    June 14, 2021
    Report Date
    June 14, 2021
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CKB
    PMA / PMN Number
    K163127
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE SUSPECT DEVICE WAS NOT RETURNED FOR INVESTIGATION. HOWEVER, VYAIRE MEDICAL INSTRUCTED THE CUSTOMER TO UPDATE THE SOFTWARE AND SINCE THE SOFTWARE WAS UPDATED TO V6.0.1700.0 (TOUCH CONFIGURATION TNXCF00129-A4 INCLUDED) THE ISSUE WAS RESOLVED. THE PRODUCTION FLOOR IS AWARE OF THE ISSUE, WHICH IS BASED ON TOUCH CONFIGURATION TNXCF00129-A3. THE CO_10212 CONTAINS ADDITIONAL TECHNICAL INFORMATION. THIS COMPLAINT WILL BE INCLUDED WITH ON-GOING TRENDING ANALYSIS. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. HOWEVER, THE CUSTOMER WILL REPLACE THE VENTILATOR AND CONTACT VYAIRE MEDICAL TO TROUBLESHOOT THE DEVICE. NO ROOT CAUSE HAS BEEN DETERMINED YET BECAUSE THE INVESTIGATION IS STILL ON GOING.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 FREEZING AND THERE IS NO INPUT POSSIBLE BUT IT STARTED WORKING AGAIN AFTER A WHILE. THE ISSUE OCCURRED DURING PATIENT USE AND AN ALTERNATIVE VENTILATOR IS PROVIDED. FURTHERMORE, THERE IS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033102 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CKB IMTMEDICAL AG BELLAVISTA 1000E

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention