BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAVISTA

    MDR report key: 18488736 · Received January 10, 2024

    Report

    Report Number
    3004553423-2024-02122
    Event Type
    Injury
    Date Received
    January 10, 2024
    Date of Event
    December 15, 2023
    Report Date
    January 10, 2024
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CBK
    UDI-DI
    07640149388183
    PMA / PMN Number
    K163127
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: VYAIRE MEDICAL WAS NOT ABLE TO CONFIRM THE ISSUE AS THERE WAS NO LOGS AVAILABLE. AS PER NOTES ON (B)(4) VYAIRE TECHNICAL PERSONAL VISITED THE SITE AND VERIFICATIONS PERFORMED ON THIS UNIT AND UNABLE TO REPLICATE THE REPORTED ISSUE. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    H10:A VYAIRE FIELD SERVICE REPRESENTATIVE(FSR) EVALUATED THE DEVICE ONSITE, RAN THE VENT FOR 30 MINS AND COULD NOT DUPLICATE THE ERROR.THE CIRCUIT TEST ANDVERIFICATION TEST PERFORMS WITHIN OEM (ORIGINAL EQUIPMENT MANUFACTURER)SPECIFICATIONS.THE UNIT WAS HANDED BACK TO STAFF TO BE PLACED BACK IN SERVICE.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 THAT THE BELLAVISTA1000 US IS ALARMING CIRCUIT OCCLUSION WHILE ON A PATIENT.THE VENTILATOR WAS REMOVED. FURTHERMORE, THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889075 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA 1000 US 07640149388183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention