BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVEA VENTILATOR

    MDR report key: 7049659 · Received November 21, 2017

    Report

    Report Number
    2021710-2017-07009
    Event Type
    Death
    Date Received
    November 21, 2017
    Date of Event
    October 30, 2017
    Report Date
    November 21, 2017
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VYAIRE'S IN-COUNTRY BUSINESS PARTNER SERVICE GROUP REPORTED EVALUATING THE VENTILATOR DEVICE. THE VENTILATOR DEVICE WAS CYCLED FOR TWENTY-FOUR HOURS WITHOUT ANY ANOMALIES. THE SERVICE GROUP WAS UNABLE TO DUPLICATE THE REPORTED EVENT. THE SUSPECT VENTILATOR DEVICE IS CURRENTLY UNAVAILABLE FOR FURTHER ANALYSIS AND NO RETURN GOOD AUTHORIZATION (RGA) HAS BEEN ISSUED BY VYAIRE. IN THE EVENT THAT THE DEVICE IS RECEIVED FOR EVALUATION OR ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE VENTILATOR WAS IN USE WITH A PATIENT, THE TOUCHSCREEN WAS UNRESPONSIVE, THE VENTILATOR WAS NOT DELIVERING THE SET PARAMETERS, AND NO AUDIBLE ALARM WAS PRESENT. THE PATIENT WAS FOUND TO BE PULSELESS AND DEVELOPED A CARDIAC ARREST. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND ATTACHED TO A MANUAL RESUSCITATION BAG FOR MANUAL VENTILATION. ANOTHER VENTILATOR DEVICE WAS ATTACHED TO THE PATIENT AND WAS GIVEN CARDIO-PULMONARY RESUSCITATION ACCORDING TO THE FACILITY PROTOCOL. HOWEVER, ACCORDING TO THE CUSTOMER THE PATIENT COULD NOT BE REVIVED DESPITE THE BEST POSSIBLE MEASURES AND THE PATIENT WAS DECLARED DEAD BY THE FACILITY MEDICAL STAFF. THE CUSTOMER REPORTED THAT THEIR BIOMEDICAL ENGINEERS EVALUATED THE VENTILATOR THOROUGHLY AND WAS UNABLE TO IDENTIFY ANY ABNORMALITIES, FAULTS, OR ERROR MESSAGES IN THE EVENT LOG RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827448 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC AVEA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Death