BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 16742360 · Received April 14, 2023

    Report

    Report Number
    16742360
    Event Type
    Malfunction
    Date Received
    April 14, 2023
    Date of Event
    March 15, 2023
    Report Date
    April 10, 2023
    Manufacturer
    IMTMEDICAL PTE. LTD
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE VYAIRE BELLAVISTA VENTILATOR SHUT DOWN WHILE IT WAS BEING USED ON A PATIENT. WE COULD NOT RESET THE SYSTEM SO IT HAD TO BE SWITCHED OUT WITH A NEW ONE. MANUFACTURER RESPONSE FOR BELLAVISTA VENTILATOR, BELLAVISTA (PER SITE REPORTER). THE BELLAVISTA CASE NUMBER IS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305374 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL PTE. LTD 1000

    Patients

    Seq Age Sex Outcome Treatment
    1 15695 DA Unknown