BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAVISTA

    MDR report key: 11364517 · Received February 23, 2021

    Report

    Report Number
    3004553423-2021-00857
    Event Type
    Injury
    Date Received
    February 23, 2021
    Date of Event
    January 21, 2021
    Report Date
    January 21, 2021
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CBK
    UDI-DI
    07640149380019
    PMA / PMN Number
    K163127
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: VYAIRE MEDICAL WAS UNABLE TO VERIFY THE CUSTOMER'S REPORTED ISSUE. EXACT ROOT CAUSE NOT ESTABLISHED. IT IS MOST LIKELY THAT THE EPC IS CAUSING THE ISSUE. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    VYAIRE MEDICAL PERFORMED LOG TOOL ANALYSIS AND CONFIRMED THE DEVICE WAS WORKING NORMALLY. THE ROOT CAUSE CANNOT BE ESTABLISHED. ACCORDING TO TECHNICAL SUPPORT IT IS MOST LIKELY THAT THE EPC (EMBEDDED POWER PC) IS CAUSING THE ISSUE. 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 · 1

    IT IS REPORTED TO VYAIRE MEDICAL THAT THE BELLAVISTA 1000 EXPERIENCED AN UNEXPECTED SHUTDOWN WHILE ON A PATIENT. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261713 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA 1000 07640149380019

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention