BEUDAMED
    FDA Enforcement Class I Terminated

    Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.

    Recall: Z-0827-2016 · Reported March 2, 2016

    Enforcement

    Recall Number
    Z-0827-2016
    Event ID
    73241
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Draeger Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 2, 2016
    Initiation Date
    February 4, 2016
    Classification Date
    February 25, 2016
    Termination Date
    April 1, 2020
    Address
    3135 Quarry Rd, N/A, Telford, PA, 18969-1042, United States

    Description

    Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.

    Reason

    The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Care was rapidly and unexpectedly reduced, despite using the most recent power supply firmware version 1.50 released in November 2015 (recall Z-0436-2016). The batteries were prematurely discharged, even though an adequate battery charge status was displayed on the device.

    Code Info

    Catalog #s 8416400 and 8417400

    Distribution

    US Nationwide Distribution including Puerto Rico.

    Quantity

    2553