BEUDAMED
    FDA Recall 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 · Initiated December 1, 2015

    Recall

    Recall Number
    Z-0436-2016
    Event Number
    72754
    Firm
    Draeger Medical, Inc.
    FEI Number
    2517967
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 1, 2015
    Posted
    December 23, 2015
    Terminated
    April 3, 2020
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    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.

    Action

    Draeger Medical, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated November 2015 to all affected consignees. The letter identified the product, problem, and actions to be taken by the customers. The Battery Charging Software will be updated and, if necessary, the batteries replaced in all affected devices Free of Charge.

    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