BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0827-2016 · Initiated February 4, 2016

    Recall

    Recall Number
    Z-0827-2016
    Event Number
    73241
    Firm
    Draeger Medical, Inc.
    FEI Number
    2517967
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 4, 2016
    Posted
    February 25, 2016
    Terminated
    April 1, 2020
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    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.

    Action

    Draeger Medical, Inc. will send an Urgent Medical Device Recall Letter to consignees in a method that confirms delivery. For consignees that have received new devices with firmware version 1.50 (127 devices) or through device updates (644 devices; reference Recall Z-0436-2016), those devices will be downgraded to firmware version 1.49 and the batteries replaced. Batteries will continue to be replaced for all consignees every six months until a final solution is available.

    Distribution

    US Nationwide Distribution including Puerto Rico.

    Quantity

    2553