BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAVISTA

    MDR report key: 16671128 · Received April 3, 2023

    Report

    Report Number
    3004553423-2023-01822
    Event Type
    Injury
    Date Received
    April 3, 2023
    Date of Event
    March 8, 2023
    Report Date
    April 3, 2023
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CBK
    UDI-DI
    07640149388183
    PMA / PMN Number
    K163127
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. 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: THE SUSPECT DEVICE WAS NOT RETURNED TO VYAIRE MEDICAL FOR EVALUATION. VYAIRE WAS NOT ABLE TO ESTABLISH THE EXACT ROOT CAUSE. NO HARDWARE FAILURE VISIBLE ON LOGS, ASSUMING THE ISSUE WAS RELATED WITH THE CALIBRATION AS THE FAILURE NOT PERSISTS AFTER A SUCCESSFUL CALIBRATION. LOGS AFTER CALIBRATION OF THE DEVICE IS NOT AVAILABLE. VYAIRE MEDICAL WAS NOT ABLE TO CONFIRM THE ISSUE. AS A RESOLUTION, VYAIRE TS REQUESTED TO PERFORM COMPLETE CALIBRATION ON 25 AUG 2023 AND THE OCCLUSION ALARMS WERE REPRODUCIBLE PRIOR TO THE CALIBRATION AND THE ISSUE RESOLVED AFTER A COMPLETE CALIBRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BELLAVISTA1000 US HAD AN OCCLUSION ALARM WHILE ON A PATIENT. FURTHERMORE, PATIENT WAS MOVED TO DIFFERENT VENT AND NO PATIENT HARM REPORTED ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878414 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA 1000 US 07640149388183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention