BEUDAMED
    FDA Recall Terminated

    Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus. The HT70 and HT70 Plus ventilator systems are intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces.

    Recall: Z-1171-2013 · Initiated April 5, 2013

    Recall

    Recall Number
    Z-1171-2013
    Event Number
    64851
    Firm
    Newport Medical Instruments Inc
    FEI Number
    2023050
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    April 5, 2013
    Posted
    April 26, 2013
    Terminated
    March 10, 2015
    Address
    1620 Sunflower Ave, Costa Mesa, CA, 92626-1513

    Description

    Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus. The HT70 and HT70 Plus ventilator systems are intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces.

    Reason

    Newport Medical Instruments is conducting a voluntary recall on certain Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries due to customer reports of Newport HT70 and HT70 Plus ventilators alarming and going to internal backup battery sooner than expected while the ventilator is being operated on Power Pac battery.

    Action

    Newport Medical Instruments sent an Urgent Medical Device Recall letter dated April 4, 2013, via FedEx to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers who sold the affected product to another party, or placed the affected product with a patient or healthcare provider were instructed to immediately inform the other party, patient, or healthcare provider of this action and provide them with a copy of the letter. If customers were using the affected product, they should ensure that an alternate source of power is available nearby. Customers were instructed to report any issues with Newport" HT70 and HT70 Plus ventilators or Power Pac batteries to the Technical Support group to ensure proper device reporting procedures are followed. Please call 800-451-3111, extension 500, for U.S. customers; and 714-427-5811, extension 500 for international customers and you will be given further instructions). For questions regarding this recall call 714-427-5811, ext 344. A press release was issued by the firm on 04/18/13.

    Distribution

    Worldwide Distribution - USA including US (AL, AR, AZ, CA, CO, CT, DE, FL, GA, lA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, WA, and WI. Internationally to Argentina, Australia, Bangladesh, Belgium, BoliVia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Ecuador, Egypt, France, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Ireland, Italy, Japan, Kazakhstan, Kosova, Lebanon, Lithuania, Malaysia, Mexico, Nambia, Nepal, Norway, Oman, Paraguay, Peru, Philippines, Poland, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Sri Lanka, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Viet Nam.

    Quantity

    2528 ventilators and 1864 power pac batteries