BEUDAMED
    FDA Adverse Event Death Summary report: N

    BELLAVISTA

    MDR report key: 15756769 · Received November 8, 2022

    Report

    Report Number
    3004553423-2022-01660
    Event Type
    Death
    Date Received
    November 8, 2022
    Date of Event
    August 10, 2022
    Report Date
    October 11, 2022
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CBK
    UDI-DI
    07640149388183
    PMA / PMN Number
    K163127
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. ADDITIONALLY, THE CUSTOMER CONFIRMED THAT THE VENT WAS ACTUALLY WORKING, BUT WAS NOT SUCCESSFUL IN VENTILATING THE PATIENT. 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: VYAIRE MEDICAL DID NOT RECEIVED THE SUSPECT DEVICE FOR EVALUTION. HOWEVER, LOG FILE ANALYSIS TOOL WAS UTILIZED. LOGS NOT SHOWING ANY HW FAILURE ALARMS REGISTERED ON THE REPORTED DATE (08/10/2022). ALARM 271- "O2 SUPPLY FAILED" WAS ACTIVE A FEW TIMES BUT RESET IN FEW SECONDS. THIS IS NORMAL AS O2 SUPPLY SOURCE WILL GET SWITCHED BY THE USER DEPENDS ON THE CLINICAL SITUATION. NO TREND FILES PROVIDED BY THE CUSTOMER. OUR INVESTIGATION REVEALED NO FAILURE DETECTED. AS PER THE COMPLAINT NOTES HOSPITAL BIOMED'S ALSO STATES THAT THE INCIDENT WAS NOT RELATED WITH THE BELLAVISTA. 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

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL PROBLEM WITH BELLAVISTA 1000 US WHERE THE VENT STOPPED WORKING ON A PATIENT. THE PATIENT WAS SWITCHED TO ANOTHER VENT AND DIED LATER ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285791 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA 1000 US 07640149388183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death