BEUDAMED
    FDA Recall Terminated

    The LIFEPAK 20 defibrillator/monitor is an AC powered external defibrillator with battery backup used by healthcare providers in hospital and clinic settings. Affected Product Part Numbers: 3202487-000 thru -012, 3202487-014 thru -027, 3203487-029 thru -039, 3202488-000 thru -019, U3202487-000, U3202487-015, U3202488-000.

    Recall: Z-0185-2012 · Initiated December 30, 2008

    Recall

    Recall Number
    Z-0185-2012
    Event Number
    60202
    Firm
    Physio Control, Inc.
    FEI Number
    3015876
    Product Code
    LDD
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 30, 2008
    Posted
    November 16, 2011
    Terminated
    November 21, 2011
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    The LIFEPAK 20 defibrillator/monitor is an AC powered external defibrillator with battery backup used by healthcare providers in hospital and clinic settings. Affected Product Part Numbers: 3202487-000 thru -012, 3202487-014 thru -027, 3203487-029 thru -039, 3202488-000 thru -019, U3202487-000, U3202487-015, U3202488-000.

    Reason

    When users do not disconnect the test plug and reconnect the QUIK-COMBO electrodes to the therapy cable, the test plug signal can be misinterpreted as a patient waveform.

    Action

    Physio Control sent a " Urgent Medial Device Safety Alert" letter dated January 2009, to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The letter instructed the customers to follow the Operating Instructions for AED and Manual Defibrillation mode (Section 4-Therapy, pages 58 and 61) that instructs users to "Connect therapy electrodes to the therapy cable and confirm cable connection to the defibrillator" to prevent users from mistakenly leaving the test plug and reconnect the QUIK-COMBO electrodes to the therapy cable, the test plug signal can be misinterpreted as a patient waveform. Recommendations to users who use a Therapy Cable: -Disconnect the QUIK-COMBO test plug prior to patient use -Confirm therapy electrodes - to - therapy cable connection -Confirm therapy cable - to - defibrillator connection -Confirm therapy electrodes - to - patient connection Adding 2005 American Heart Association software that includes audible and visual prompts to LIFEPAK 20 defibrillators manufactured prior to January 2007 is optional and not required. If the customers would like to have this optional kit installed in your defibrillators, please contact Physio Control, Inc. Customers can call Technical Support at 1-800-442-1142 for any questions about this recall or or visit our website at www.physio-control notices.com/LP20testplug.

    Distribution

    Worldwide Distribution--USA ( nationwide ) and the countries of Bahrain, Lebanon , Cyprus, Netherlands, Egypt, Pakistan, Germany, Saudi Arabia, India, South Africa, Iran, Syria, Israel, Turkey, Jordan, UAE,Kuwait, Yemen, Asia Pacific, Australia, New Caledonia, Guam, New Zealand, Hong Kong, Latin America, Anguilla, Jamaica, Argentina, Mexico, Bahamas, Nicaragua, Brazil, Panama, Chile, Peru, Colombia, Trinidad, Costa Rica, Uruguay, El Salvador, Venezuela, Guatemala, Virgin Islands and Canada.

    Quantity

    23,467 units worldwide