BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 15830574 · Received November 19, 2022

    Report

    Report Number
    3004553423-2022-01670
    Event Type
    Malfunction
    Date Received
    November 19, 2022
    Date of Event
    October 18, 2022
    Report Date
    October 19, 2022
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CBK
    PMA / PMN Number
    K163127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE SUSPECT DEVICE WAS NOT RETURNED TO VYAIRE MEDICAL FOR EVALUATION. VYAIRE MEDICAL WAS NOT ABLE TO CONFIRM THE ISSUE. THE EXACT ROOT CAUSE IS NOT DETERMINED AS NO DEVICE FAILURE DETECTED. MOST LIKELY IT IS DUE TO LACK OF USER TRAINING.

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BELLVISTA1000 US UNIT SETTINGS HAS CHANGED DURING MODE CHANGE WHILE ON A PATIENT. THE PATIENT WAS ON VOLUME AC AND THEN PLACED ON PSV FOR A SPONTANEOUS BREATHING TRIAL (SBT). UPON TERMINATION OF THE SBT, THE RT RETURNED THE PATIENT TO VOLUME AC AND FOR A FEW MINUTES HE DID NOT REALIZED THAT THE PATIENT VOLUME AC WAS SET TO VT AND RR HAD BEEN CHANGED FROM THEIR ORDERED VALUES TO THE LAST SPONTANEOUS VALUES. THE SETTINGS WAS RESTORED TO THEIR ORDERED VALUES AND THE PATIENT SUFFERED NO HARM DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2464996 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA 1000 US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown