BEUDAMED
    FDA Adverse Event Death Summary report: N

    3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 14811449 · Received June 24, 2022

    Report

    Report Number
    2021710-2022-16347
    Event Type
    Death
    Date Received
    June 24, 2022
    Date of Event
    November 19, 2019
    Report Date
    February 1, 2020
    Manufacturer
    VYAIRE MEDICAL INC.
    Product Code
    LSZ
    UDI-DI
    10846446003079
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100A VENTILATOR MALFUNCTIONED AND/OR SHUT OFF WITHOUT WARNING LEADING TO ACUTE DECOMPENSATION AND HYPERCAPNIA. CURRENTLY, THERE IS NO INFORMATION AS TO THE INTERVENTION THAT TOOK PLACE IN THE HOSPITAL IMMEDIATELY FOLLOWING THE REPORTED EVENT. THE PATIENT'S BLOOD WAS TESTED AND THEIR BLOOD CULTURE CAME BACK POSITIVE. THE PATIENT WAS PLACED ON ANTIBIOTICS TO TREAT THE POSITIVE BLOOD CULTURE. THE DOCTORS RECOMMENDED TO THE PATIENT'S PARENTS THAT THEY REMOVED SUPPORT. THE PATIENT PASSED AWAY ONCE SUPPORT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055109 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ VYAIRE MEDICAL INC. 3100 A 10846446003079

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Unknown Death