BEUDAMED
    FDA Recall Terminated

    Physio-Control LIFEPAK 20e defibrillator/monitor, sold internationally only, is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.

    Recall: Z-1906-2008 · Initiated April 16, 2008

    Recall

    Recall Number
    Z-1906-2008
    Event Number
    47822
    Firm
    Physio Control, Inc.
    FEI Number
    3015876
    Product Code
    LDD
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 16, 2008
    Posted
    September 16, 2008
    Terminated
    March 29, 2011
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    Physio-Control LIFEPAK 20e defibrillator/monitor, sold internationally only, is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.

    Reason

    The LIFEPAK 20e defibrillator / monitors with software versions 058 have an increase in likelihood for an incorrect Shock Advisory Algorithm (SAS) decision if the Auto Analyze setting in AED mode is On, leading to incorrectly render of shock or no shock decision. When Auto Analyze is set to On in AED mode the device initiates the SAS analysis immediately (no waiting period or warning prior to anal

    Action

    On April 16, 2008, a letter was sent to the firms customers, via certified mail explaining the recall, giving product and software version information, request for customer to forward the notification to all sites and recommending the following: "Keep the defibrillator in service... Check the Auto Analyze Setup Option for each of your devices. If Auto Analyze is set to ON, change the setting to one of the other two choices: OFF or After First Shock... Follow the enclosed instructions to confirm or change the Auto Analyze Setup Option setting...If you update your defibrillator with new software, confirm the Auto Analyze Setup Option is set to OFF or After First Shock". Instructions for changing the auto analyze setup option for the LP 12 and LP20 were attached to the letter. There was no software issued in response to this action. Since LP20 customers may purchase a software program allowing them to update their defibrillator software, the letter recommends confirming Auto Analyze Setup Option is set to OFF or After First Shock if new software is installed . The default setting for the software update is Auto-Analyze ON. Contact Technical Support at 1-800-442-1142, option 5 - 6:00 a.m. to 4:00 p,m, (Pacific), Monday - Friday or visit www.Physio-Control-notices.com/sas if you have questions.

    Distribution

    Product distributed nationwide and includes: 2 distributors, 157 direct accounts, 2,069 hospitals, 51 Department of Defense accounts, 58 miscellaneous government accounts, 3,295 first responders, 43 international accounts. International accounts are located in the following countries: ARGENTINA, AUSTRALIA, BARBADOS, BOLIVIA, BRAZIL, CANADA, CAYMAN ISLANDS, CHILE, COSTA RICA, DOMINICAN REPUBLIC, GERMANY, GUAM, GUATEMALA, GUYANA, HONG KONG, JAMAICA, JAPAN, MEXICO, NETHERLANDS ANTILLES, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, PANAMA, PARAGUAY, PERU, PUERTO RICO, TRINIDAD, UNITED STATES, URUGUAY, and VIRGIN ISLANDS.

    Quantity

    969 units