BEUDAMED
    FDA Enforcement Class I Terminated

    Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients.

    Recall: Z-0436-2016 · Reported December 30, 2015

    Enforcement

    Recall Number
    Z-0436-2016
    Event ID
    72754
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Draeger Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2015
    Initiation Date
    December 1, 2015
    Classification Date
    December 23, 2015
    Termination Date
    April 3, 2020
    Address
    3135 Quarry Rd, N/A, Telford, PA, 18969-1042, United States

    Description

    Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients.

    Reason

    The firm became aware of cases in which the battery run times of the optional PS 500 power supply unit with the Infinity Workstation Critical Care (Evita Infinity V 500) were unexpectedly short due to the design of the charging algorithm in the current software. Devices used for patient transport will be a priority.

    Code Info

    Catalog numbers: 8416400/8417400 distributed June 2011 October 2015.

    Distribution

    US Nationwide-including DC and PR, and the states of AK; AR; AZ; CA; CO; CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD; TN; TX; UT; VA; VT; WA; WI; and WV.

    Quantity

    2422