BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 18176385 · Received November 20, 2023

    Report

    Report Number
    3004553423-2023-02052
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    October 27, 2023
    Report Date
    November 20, 2023
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    07640149388879
    PMA / PMN Number
    K163127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE SUSPECT DEVICE WAS NOT RETURNED TO VYAIRE MEDICAL FOR EVALUATION, THEREFORE, A DEFINITIVE ROOT CAUSE COULDN'T BE DETERMINED. PLV ALARMS ARE VISIBLE ON THE LOGS TOGETHER WITH OCCLUSION ALARMS. WITH THE AVAILABLE DATA'S FROM THE LOGS, THE ISSUE APPEARED WITH ADULT PATIENTS. THE SET TIDAL VOLUME WAS NOT ACHIEVABLE WITH THE MAXIMUM ALLOWED AIRWAY PRESSURE (PPEAK UPPER ALARM LIMIT -5MBAR), THEREFORE THE PLV (PRESSURE LIMITED VENTILATION) LUNG PROTECTION SAFETY FEATURE HAS KICKED-IN AS DESIGNED AND THE MACHINE HAS ALARMED ACCORDINGLY ALARM 105 - "VOLUME LOW (PLV PRESSURE-LIMITED)".

    Additional Manufacturer Narrative · 0

    H10: AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. HOWEVER, VYAIRE TS RECEIVED LOGS DATED FROM AUG AND FOUND THAT ALL 260/262 ALARMS WERE IN ADULT MODE. 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 BELLAVISTA1000E US GIVING A REPEATING AND NUISANCE 260/262 CIRCUIT OCCLUSION ALARMS WHILE ON VERY LOW BIRTHWEIGHT BABIES IN NICU (NEONATAL INTENSIVE CARE UNIT). FURTHERMORE, THERE WAS NO INFORMATION REGARDING PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1993075 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL BELLAVISTA 1000E US 17,3" VENTILATOR 07640149388879

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown