BEUDAMED
    FDA Recall Terminated

    Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.

    Recall: Z-1693-2021 · Initiated April 16, 2021

    Recall

    Recall Number
    Z-1693-2021
    Event Number
    87819
    Firm
    Draeger Medical, Inc.
    FEI Number
    2517967
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 16, 2021
    Terminated
    February 6, 2024
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.

    Reason

    Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning

    Action

    In April, 2021, Draeger issued an Urgent Medical Device Correction notice to customer via letter notifying them that Draeger became aware of three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800:

    Distribution

    US Nationwide distribution in the states of PA, TX, MD, FL, TX, WA, MS, NY.

    Quantity

    12 units