BEUDAMED
    FDA Recall Terminated

    Biphasic LIFEPAK 15 Monitor/Defibrillator. The LIFEPAK 15 is a battery operated monitor with an external portable defibrillator used by healthcare providers in EMS, hospital and clinic settings. It operates in a manual or semi-automatic defibrillation mode and is offered with optional monitoring functions including Non-Invasive Blood Pressure (NIBP). When clinically indicated the LIFEPAK 15 allows the operator to deliver a brief, high energy, external shock through the chest to a patient's heart.

    Recall: Z-2110-2009 · Initiated August 12, 2009

    Recall

    Recall Number
    Z-2110-2009
    Event Number
    53087
    Firm
    Physio Control, Inc.
    FEI Number
    3015876
    Product Code
    DXN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 12, 2009
    Posted
    September 18, 2009
    Terminated
    August 10, 2012
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    Biphasic LIFEPAK 15 Monitor/Defibrillator. The LIFEPAK 15 is a battery operated monitor with an external portable defibrillator used by healthcare providers in EMS, hospital and clinic settings. It operates in a manual or semi-automatic defibrillation mode and is offered with optional monitoring functions including Non-Invasive Blood Pressure (NIBP). When clinically indicated the LIFEPAK 15 allows the operator to deliver a brief, high energy, external shock through the chest to a patient's heart.

    Reason

    Some LIFEPAK 15 Monitor/Defibrillators have a Non-Invasive Blood Pressure (NIBP) module that was supplied by CAS Medical Systems, Branford, Connecticut who is recalling the modules. The NIBP modules may be susceptible to sudden changes in cuff pressure. Sudden changes in cuff pressure may possibly be caused by bumping or squeezing the cuff. In some instances this may result in a screen display

    Action

    The firm notified customers by letter dated August 2009. Customers will have the Noninvasive Blood Pressure (NIBP) module replaced. If additional questions about the notification, contact Technical Support by calling 1-800-442-1142, option 5, Monday-Friday 6:00 a.m. to 4:00 p.m. (Pacific Standard Time). .

    Distribution

    Worldwide Distribution -- US, AUSTRALIA, GERMANY and NETHERLANDS.

    Quantity

    445 devices worldwide