BEUDAMED
    FDA Adverse Event Death Summary report: N

    BELLAVISTA

    MDR report key: 9255610 · Received October 30, 2019

    Report

    Report Number
    3004553423-2019-00453
    Event Type
    Death
    Date Received
    October 30, 2019
    Date of Event
    October 28, 2019
    Report Date
    October 28, 2019
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CBK
    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

    DEVICE EVALUATION: G4, H2, H3, H6 AND H10. RESULTS OF INVESTIGATION: UPON COMPLETION OF ANALYSIS, IT WAS DETERMINED THAT THE REPORTED ALARM SEQUENCE WITH TECHNICAL FAILURE 379 - "NO O2 DOSING POSSIBLE" IN COMBINATION WITH ALARM 271 - "O2 SUPPLY FAILED - NO O2 DOSING POSSIBLE" IS REPRODUCIBLE. THE ALARMS ARE CAUSED BY A DEFECTIVE O2 PRESSURE REGULATOR ON THE INSPIRATION BLOCK. THE FLUCTUATION OF THE REGULATED OUTPUT PRESSURE IS TOO HIGH, THAT RESULTS IN SHORT PERIODS OF TOO HIGH OUTPUT PRESSURE. THIS TRIGGERS THE REPORTED ALARM SEQUENCE AND INFORMS THE USER WITH A HIGH PRIORITY ALARM MESSAGE "NO O2 DOSING POSSIBLE". AS EXPECTED AND DESIGNED, AS LONG AS THE REGULATED PRESSURE IS OUT OF THE SPECIFIED / VALID RANGE, THE HIGH PRIORITY ALARM "NO O2 DOSING POSSIBLE" IS ACTIVE AND THE O2 PATH IS SHUT-DOWN (FOR SAFETY REASON). THE VENTILATION TO THE PATIENT CONTINUES ALL THE TIME AND THE O2 CONCENTRATION FALLS BACK TO 21% (BLOWER AIR ONLY), AS THE O2 PATH IS CLOSED BY THE O2 SAFETY VALVE. AS SOON THE REGULATED PRESSURE IS BACK WITHIN THE EXPECTED RANGE, THE ALARMS ARE RESET AND THE O2 PATH GETS RE-ACTIVATED. THE VENTILATION TO THE PATIENT RETURNS TO THE PRIORY SET O2 CONCENTRATION. (E.G. 100% O2). FURTHER INVESTIGATION OF THE DEFECTIVE PRESSURE REGULATOR HAS BEEN PERFORMED THROUGH CAPA INVESTIGATION I_CH-19-042. CONFIRMED ROOT CAUSE: RESTRICTION OF THE P2 REGULATOR HOLE CAUSED BY INJECTION MOLDING DEBURRS DURING MANUFACTURING COMPROMISES THE DYNAMIC BEHAVIOR OF THE PRESSURE REGULATOR. THIS LEADS TO OVERSHOOTING OF THE INTERNAL O2 PRESSURE "PRESS O2 REGULATED", TRIGGERS THE ALARM "TECHNICAL FAILURE 388 - NO O2 DOSING POSSIBLE" AND LEADS TO THE O2 GAS PATH SHUT-DOWN BY THE BELLAVISTA SOFTWARE (SAFETY PROCEDURE).

    Additional Manufacturer Narrative · 1

    AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FOR EVALUATION. LOG FILES WERE PROVIDED BUT INVESTIGATION IS STILL ONGOING. ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE ALARMED TF 379 OR NO O2 DOSING POSSIBLE DURING VENTILATION OF A PATIENT. THE END USER HAD TO REMOVE THE PATIENT FROM THE SUSPECT DEVICE TO A BACKUP VENTILATOR; HOWEVER, IT WAS REPORTED THAT THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050469 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA 1000E

    Patients

    Seq Age Sex Outcome Treatment
    1 Death