BEUDAMED
    FDA Adverse Event Death Summary report: N

    BELLAVISTA

    MDR report key: 12484291 · Received September 16, 2021

    Report

    Report Number
    3004553423-2021-01177
    Event Type
    Death
    Date Received
    September 16, 2021
    Date of Event
    August 19, 2021
    Report Date
    August 19, 2021
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CBK
    UDI-DI
    07640149388879
    PMA / PMN Number
    K163127
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION UPDATE: RESULTS OF INVESTIGATION: THE SUSPECT DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, VYAIRE FIELD SERVICE REPRESENTATIVE (FSR) ARRIVED ON SITE AND SAW THAT THE UNIT WAS ON SOFTWARE VERSION 6.17. THE UNIT WAS THEN UPGRADED TO SOFTWARE VERSION 6.19, AND LOGS AND TRENDING DATA WERE DOWNLOADED. FILES WERE SENT TO TECH SUPPORT TO BE ANALYZED. THE RESPONSE FROM TECH SUPPORT WAS TO PERFORM A FULL UNIT VERIFICATION. WHEN SEARCHING FOR THE UNIT, THE CUSTOMER STATES THAT THE UNIT WAS SHIPPED TO CORPORATE AND THAT NO VENT REPAIR CAN BE PERFORMED. THE CUSTOMER IS RESPONSIBLE FOR INFORMING THE RECIPIENT OF THE VENTILATOR THAT THE UNIT SHOULD NOT BE USED ON PATIENTS UNTIL IT HAS BEEN SERVICED BY VYAIRE. ROOT CAUSE OF FAILURE WAS NOT REPRODUCIBLE, THERE WAS NO ISSUE NOTICED ON THE LOGS AND TREND FILES. THIS COMPLAINT WILL BE INCLUDED WITH ON-GOING TRENDING ANALYSIS. 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 FILE IDENTIFICATION: (B)(4). 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE SCREEN OF BELLAVISTA 1000E US HAD FROZEN AND THAT THE PATIENT WAS NOT RECEIVING ANY FLOW OR OXYGEN. THE PATIENT STATED THAT THE DEVICE MADE A STRANGE SPUTTERING NOISE COMING FROM THE MACHINE AND THEN ABRUPTLY STOPPED WORKING. IT CAME TO A HALT FOR ABOUT 10 MINUTES, ACCORDING TO THE PATIENT. IT TOOK 20 MINUTES FOR THE PATIENT'S O2 SAT TO RISE TO 88%. THE DEVICE HAS BEEN RESTARTED, REMOVED FROM SERVICE, AND REPLACED WITH AN AIRVO; IT IS NOW IN THE SUPPLY ROOM, BAGGED, AND TAGGED. FURTHERMORE, THE CUSTOMER CONFIRMED THAT THE PATIENT HAD TEMPORARILY OXYGEN DESATURATION DUE TO THE LOSS OF FLOW AND OXYGEN. THE TEAM WAS ABLE TO SUPPORT THE PATIENT BY MANUALLY VENTILATING WITH A BAG/MASK UNTIL THE VENTILATOR COULD BE SWITCHED. THE PATIENT ENDED UP PASSING AWAY DUE TO OTHER CAUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382149 BELLAVISTA VENTILATOR, CONTINOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA 1000E US 07640149388879

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D