BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAVISTA

    MDR report key: 20440951 · Received October 14, 2024

    Report

    Report Number
    3013421741-2024-00492
    Event Type
    Injury
    Date Received
    October 14, 2024
    Date of Event
    July 5, 2024
    Report Date
    October 14, 2024
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K183364
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). D4: UNIQUE IDENTIFIER (UDI)#: UNABLE TO DETERMINE ENTIRE UDI# AS INFORMATION WAS NOT PROVIDED. G4: PMA/510(K)#: THE DEVICE IS A SIMILAR DEVICE MARKETED IN FOREIGN COUNTRIES AND IS NOT MARKETED UNDER THE 510K. H3: 81 OTHER: 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.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION UPDATE: G3, G6, H2, H6 AND H11. THE ORIGINAL COMPLAINT WAS NOT CONFIRMED. A REVIEW OF THE LOG FILE FOR BV MB 170599 FOUND NO EVIDENCE OF ALARMING WHILE ON A PATIENT FOR THE DATE AND TIME PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR WAS EXPERIENCING FIO2 ISSUES. THIS INCIDENT OCCURRED WHILE ON A PATIENT AND IT TOOK 1 MONTH TO BE REPORTED. THE ERROR MESSAGE APPEARED ON THE VENTILATOR AND WAS IN USE ON THE PATIENT. THE FI02 WAS INCREASED TO 100% FI02 AS THE PATIENT DESATURATED WHILE BEING REPOSITIONED. ONCE THE FI02 WAS WEANED THIS ERROR STARTED APPEARING EVERY 20 SECONDS. THE PATIENT HAS NOT DESATURATED HOWEVER THEY SWAPPED THE VENTILATOR FOR ANOTHER ONE FOR SAFETY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE CUSTOMER SENT OVER LOG FILES FOR FURTHER INVESTIGATION. THE FILES WERE REVIEWED AND THE ORIGINAL COMPLAINT WAS NOT CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2230874 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL 301.100.100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention