BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVEA

    MDR report key: 9541003 · Received January 2, 2020

    Report

    Report Number
    2021710-2020-11233
    Event Type
    Death
    Date Received
    January 2, 2020
    Date of Event
    December 8, 2019
    Report Date
    December 9, 2019
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    10846446000368
    PMA / PMN Number
    K103211
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE SUSPECT COMPONENT IS NOT AVAILABLE FOR ANALYSIS AND NO RETURN GOOD AUTHORIZATION (RGA) HAS BEEN ISSUED. AT THIS TIME, VYAIRE MEDICAL HAS NOT RECEIVED THE SUSPECT COMPONENT FOR EVALUATION. 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 A PATIENT DEATH AND NO AUDIBLE ALARM, WHILE IN USE ON THIS VENTILATOR DEVICE. THE CUSTOMER STATED NO FURTHER INFORMATION RELATING TO THIS INCIDENT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4277 AVEA VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL AVEA 10846446000368

    Patients

    Seq Age Sex Outcome Treatment
    1 Death