BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALMTOP VENTILATOR, MODELS PTV-8, PTV-10

    MDR report key: 12643802 · Received October 16, 2021

    Report

    Report Number
    2021710-2021-14779
    Event Type
    Death
    Date Received
    October 16, 2021
    Date of Event
    September 20, 2021
    Report Date
    September 20, 2021
    Manufacturer
    VYAIRE MEDICAL INC.
    Product Code
    CBK
    UDI-DI
    00845873000005
    PMA / PMN Number
    K070594
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS RETURNED AND EVALUATION IS ANTICIPATED BUT NOT YET BEGUN. ONCE A FINAL INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE DEVICE MALFUNCTIONED DURING USE ON A PATIENT ON THE ENVE VENTILATOR. THE CUSTOMER REPORTED PATIENT CODED THEN LATER ON EXPIRED WHILE CONNECTED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541707 PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL INC. ENVE VENTILATOR 00845873000005

    Patients

    Seq Age Sex Outcome Treatment
    1 Death