BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAVISTA

    MDR report key: 15127195 · Received July 28, 2022

    Report

    Report Number
    3004553423-2022-01596
    Event Type
    Injury
    Date Received
    July 28, 2022
    Date of Event
    June 22, 2022
    Report Date
    June 28, 2022
    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

    AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. HOWEVER, VYARE MEDICAL CHECKED THE LOGS BUT NO INDICATION OF HARDWARE ISSUES ON THE DATE REPORTED. A LEAKAGE WAS DETECTED BY THE UNIT AND FOLLOWED BY A DISCONNECTION ALARM 251, THEN AN EXTERNAL O2 SUPPLY WAS REMOVED AS ALARM 271- "O2 SUPPLY FAILED TRIGGERED. LOG SHOWS THAT ALL THIS TIME THE VENTILATION IS RUNNING. ON 22ND OF JUNE AT 10:52:17, ON/ OFF SWITCH GOT PRESSED AND SEEN A " VENTILATION IS RUNNING" MESSAGE TRIGGERED. VENTILATION WAS TURNED OFF AND SHUT DOWN COMPLETED AT 10:52:25. IN SUMMARY, THE UNIT FUNCTIONED AS DESIGNED. A HARD RESET PERFORMED WHILE THE VENTILATION WAS ON, THE ABOVE SCENARIO CAN BE TRIGGERED ON ANY G6 UNIT WHILE THE UNIT IS VENTILATING. FURTHERMORE, NO ROOT CAUSE COULD BE DETERMINED YET AS THE INVESTIGATION IS STILL ONGOING. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE."

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE SUSPECT DEVICE WAS NOT RETURNED TO VYAIRE MEDICAL. THE EXACT ROOT CAUSE IS NOT DETERMINED AS NO FAILURE DETECTED. UNIT FUNCTIONED AS DESIGNED. A LEAKAGE WAS DETECTED BY THE UNIT AND FOLLOWED BY A DISCONNECTION ALARM 251 @ 22/06/2022 10:43:45 ( ASSUMING THAT COULD BE DUE TO REMOVAL OF THE CIRCUIT), THEN LOGS SHOWS THAT THE EXTERNAL O2 SUPPLY REMOVED @ 22/06/2022 10:45:21 AS ALARM 271- "O2 SUPPLY FAILED" TRIGGERED @ 22/06/2022 10:45:21, ALL THIS TIME THE VENTILATION IS RUNNING. THEN @ 22/06/2022 10:52:17 ON/ OFF SWITCH GOT PRESSED AND " VENTILATION IS RUNNING" MESSAGE TRIGGERED @ 22/06/2022 10:52:19. VENTILATION TURNED OFF AND SHUT DOWN COMPLETED @ 22/06/2022 10:52:25. ALL THE ABOVE SIGNS SHOWS A HARD RESET PERFORMED WHILE THE VENTILATION WAS ON, THE ABOVE SCENARIO CAN BE TRIGGERED ON ANY G6 UNIT WHILE THE UNIT IS VENTILATING.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BELLAVISTA1000 AUTOMATICALLY SWITCHED OFF WHILE ON A PATIENT. FURTHERMORE, PATIENT WAS TRANSFERRED TO A BACK UP VENT, BUT NO REPORTED HARM ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2440697 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA 1000 07640149380019

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention