BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 15442926 · Received September 17, 2022

    Report

    Report Number
    3004553423-2022-01631
    Event Type
    Malfunction
    Date Received
    September 17, 2022
    Date of Event
    August 22, 2022
    Report Date
    August 22, 2022
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CBK
    UDI-DI
    07640149388879
    PMA / PMN Number
    K163127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: VYAIRE MEDICAL DID NOT RECEIVED THE SUSPECT DEVICE FOR EVALUTION. HOWEVER, LOG FILE ANALYSIS TOOL HAS BEEN UTILIZED. THE ROOT CAUSE WAS DETERMINED TO BE A USER FAILURE - LOSS OF STEADY O2 SUPPLY CAUSED THE FAILURE. O2 SUPPLY PRESSURE DROP DOWN TO 0 AT (B)(6) 2022 16:53:53 (DEVICE TIME) CAUSE THE ALARM 379- "" O2 DOSING NOT POSSIBLE"", ALARM GOT RESET AT (B)(6) 2022 16:54:53 WHEN THE SUPPLY IS RESTORED. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4) 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

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL PROBLEM WITH BELLAVISTA1000E US GIVING TECHNICAL FAILURE 379 - NO O2 DOSING POSSIBLE. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125815 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA 1000E US 07640149388879

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown