BEUDAMED
    FDA Recall Terminated

    Newport HT70 Ventilator. Model #HT70, The Newport HT70 ventilator is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or noninvasive interfaces. Specifically, the Newport HT70 ventilator is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 Ibs). The Newport HT70 ventilator is suitable for use in hospital, subacute, emergency room, and home care environments as well as for transport and emergency response applications.

    Recall: Z-2406-2011 · Initiated September 20, 2010

    Recall

    Recall Number
    Z-2406-2011
    Event Number
    58619
    Firm
    Newport Medical Instruments Inc
    FEI Number
    2023050
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 20, 2010
    Posted
    June 2, 2011
    Terminated
    June 3, 2011
    Address
    1620 Sunflower Ave, Costa Mesa, CA, 92626-1513

    Description

    Newport HT70 Ventilator. Model #HT70, The Newport HT70 ventilator is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or noninvasive interfaces. Specifically, the Newport HT70 ventilator is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 Ibs). The Newport HT70 ventilator is suitable for use in hospital, subacute, emergency room, and home care environments as well as for transport and emergency response applications.

    Reason

    The recall was initiated because Newport Medical has confirmed a limited number of power cords recently received from their supplier, Glob-Tek, have a slightly oversized plug connector which prevents the cord from locking into place. These cords are fully functional as supplied. However, the cord can be easily disconnected. If the cord is disconnected, the HT70 will alert the user with a power di

    Action

    Newport Medical sent an PRODUCT NOTICE LETTER, dated September 20, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. Customers were instructed to discard the original cord and only use the replacement cord to avoid unintentional disconnection of the power cord. Each affected Customer was sent a replacement cord. Customers with any questions regarding the Product Notice were instructed to contact the Technical Support Department at (800) 451-3111.

    Distribution

    Worldwide Distribution--USA (nationwide) including the states of MA, PA, OH, IA and Puerto Rico and the countries of Colombia, UAE, Hong Kong, Hungary, India, Japan, Nepal, China, Philippines, Singapore and South Africa.

    Quantity

    22 units total