BEUDAMED
    FDA Recall Terminated

    The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e. Product part numbers: 3202487-xxx, 3202488-000, U3202487-000, 3202488-015, and U3202488-000. The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e are acute cardiac care devices used by authorized healthcare providers in hospital and clinic settings. It is commonly found on "code" or "crash" cars in hospital hallways, plugged into AC power. In an emergency the user retrieves the cart, unplugging the monitor, and uses the device with the door closed for easy 1-2-3 operation. When the code team arrives the user will open the door and have access to all functions, including ECG monitoring. In addition to functioning as a semi-automatic defibrillator the LIFEPAK 20/20e provides options for: ECG monitoring, manual mode defibrillation; Non-invasive pacing; synchronized cardioversion; pulse oximetry (SpO2); hard paddles (adult and pediatric) and internal paddle accessories; printing; and backup batter power. The units are biphasic waveform devices

    Recall: Z-1722-2011 · Initiated May 27, 2010

    Recall

    Recall Number
    Z-1722-2011
    Event Number
    55875
    Firm
    Physio Control, Inc.
    FEI Number
    3015876
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 27, 2010
    Posted
    March 18, 2011
    Terminated
    September 29, 2014
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e. Product part numbers: 3202487-xxx, 3202488-000, U3202487-000, 3202488-015, and U3202488-000. The LIFEPAK 20 defibrillator/monitor and LIFEPAK 20e are acute cardiac care devices used by authorized healthcare providers in hospital and clinic settings. It is commonly found on "code" or "crash" cars in hospital hallways, plugged into AC power. In an emergency the user retrieves the cart, unplugging the monitor, and uses the device with the door closed for easy 1-2-3 operation. When the code team arrives the user will open the door and have access to all functions, including ECG monitoring. In addition to functioning as a semi-automatic defibrillator the LIFEPAK 20/20e provides options for: ECG monitoring, manual mode defibrillation; Non-invasive pacing; synchronized cardioversion; pulse oximetry (SpO2); hard paddles (adult and pediatric) and internal paddle accessories; printing; and backup batter power. The units are biphasic waveform devices

    Reason

    A component failure on the AC power supply assembly results in "NO AC POWER" operation. A failure of AC power can result in a delay of defibrillation therapy if backup battery power is depleted.

    Action

    PhysioControl, Inc. began sending an Urgent Medical Device Correction letter via certified receipt to all affected customers describing the potential issue. Customers were advised to keep the defibrillators in service and to follow the daily Operator's Checklist. All power supplies will be updated. For questions customers were instructed to contact Technical Support at 1-800-442-1142. For questions regarding this recall call 425-867-4000.

    Distribution

    Worldwide distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MI, MD, MI, NC, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY and the coutnries of ANGUILLA, ARGENTINA, AUSTRALIA, BAHAMAS, BAHRAIN, BARBADOS, BOLIVIA, BRAZIL, CAYMAN ISLANDS, CHILE, COLOMBIA, COSTA RICA, CYPRUS, DOMINICAN REPUBLIC, EGYPT, EL SALVADOR, GERMANY, GUAM, GUATEMALA, HONG KONG, INDIA, IRAN, ISRAEL, JAMAICA, JORDAN, KUWAIT, LEBANON, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, PAKISTAN, PANAMA, PARAGUAY, PERU, PUERTO RICO, SAUDI ARABIA, SOUTH AFRICA, SYRIA, TRINIDAD, TRINIDAD AND TOBAGO, TURKEY, UKRAINE, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA, VIRGIN ISLANDS, and YEMEN.

    Quantity

    53550 units