BEUDAMED
    FDA Recall Terminated

    Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 The rechargeable lithium-ion batteries are intended to provide a backup power source to the ventilator in case AC power is lost.

    Recall: Z-1208-2018 · Initiated November 21, 2017

    Recall

    Recall Number
    Z-1208-2018
    Event Number
    79371
    Firm
    Covidien LLC
    FEI Number
    1219930
    Product Code
    CBK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 21, 2017
    Terminated
    July 10, 2020
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908

    Description

    Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042; UDI: 20884521700861 The rechargeable lithium-ion batteries are intended to provide a backup power source to the ventilator in case AC power is lost.

    Reason

    Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Bennett 980 ventilators may not fully charge after installation.

    Action

    Consignees are instructed to immediately notify all care environments in which the PB980 ventilators are used about the notification. If the facility has distributed PB980 ventilators to other persons or facilities, they are asked to please promptly forward a copy of the letter to those recipients. The consignee is asked to complete an attached form and return it as directed to confirm receipt and understanding of the notification.The firm developed a tool to inspect and identify the firmware on the batteries. Medtronic service engineers will inspect batteries at consignee facilities during scheduled or preventive maintenance. Batteries found to have the incorrect firmware will be replaced. For further questions, please call (203) 492-5415.

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, and the District of Columbia. and to the countries of : Argentina, Chile, Mexico, Panama, Canada, Australia, New Zealand, Austria, Bahrain, Belgium, Bulgaria, Croatia, Czech Republic, Egypt, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Jordan, Kuwait, Latvia, Lebanon, Lithuania, Morocco, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom, Israel, Netherlands, Tunisia, Brunei, Indonesia, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam

    Quantity

    15,885