BEUDAMED
    FDA Recall Terminated

    The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and is intended for use in the pre-hospital and workplace and community environments.

    Recall: Z-1773-2013 · Initiated June 12, 2013

    Recall

    Recall Number
    Z-1773-2013
    Event Number
    65565
    Firm
    Physio Control, Inc.
    FEI Number
    3015876
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    June 12, 2013
    Posted
    July 19, 2013
    Terminated
    September 19, 2013
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and is intended for use in the pre-hospital and workplace and community environments.

    Reason

    The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. If affected, the malfunction would be the result of internal shorting on a printed circuit board assembly and could render the device inoperable.

    Action

    The firm, Physio-Control Inc., contacted their consignees by telephone or email starting on June 13, 2013 and sent and/or delivered an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 2013 to its customers. The letter described the product, problem and actions to be taken. A Physio-Control representative will be contacting the customers by direct visit, telephone, or email you to coordinate the replacement of their device(s). Customers with questions regarding this notification, please call Physio's Technical Support at 1-800-442-1142, 6:00 a.m. to 4:00. pm. (Pacific), Monday-Friday.

    Distribution

    Worldwide distribution: US (nationwide) including states of: IL, MA, NC, ND, NY, PA, RI, TX, WA, and WI; and country of: Canada.

    Quantity

    139 total (125 units in the US and 14 units outside US)