BEUDAMED
    FDA Recall Terminated

    LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.

    Recall: Z-1123-2017 · Initiated January 12, 2017

    Recall

    Recall Number
    Z-1123-2017
    Event Number
    76160
    Firm
    Physio-Control, Inc.
    FEI Number
    3015876
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 12, 2017
    Posted
    February 11, 2017
    Terminated
    September 1, 2017
    Address
    11811 Willows Rd NE, Redmond, WA, 98052-2003

    Description

    LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.

    Reason

    The firm has become aware of a potential device issue where the LIFEPAK 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (Relay) installed on the Therapy Printed Circuit Board Assembly (PCBA).

    Action

    Physio plans to send the URGENT MEDICAL DEVICE CORRECTION ACTION REQUIRED LIFEPAK 15 Monitor/Defibrillator letter, dated January 2017, to their consignees on January 12, 2017. They were informed of the problem and how to identify a malfunction during the User Test of the device as described in the chapter titled Maintaining the Equipment within the LIFEPAK 15 Operating Instructions (or follow page 2 of the notification letter). If the User Test fails, the device will illuminate the Service indicator on the device. Please contact Physio-Control immediately to schedule the device correction. This field corrective action will include replacement of the Therapy PCB assembly on all devices included in the potentially affected population. This will occur as a combination of field and depot service. Customers are required to take the following actions: 1. Please forward this letter to all of your sites, trainers and users that have an affected LIFEPAK 15 device as identified on the attached Confirmation Sheet. 2. Follow the instructions on the Confirmation Sheet for each serial number listed in your possession. Promptly return the completed Confirmation Sheet to Physio-Control. 3. If the device fails the User Test, as described above, contact Physio-Control immediately to arrange for correction of your device. 4. Continue to perform the User Test as outlined in the Daily Operators Checklist within the LIFEPAK 15 Operating Instructions. Consignees should return completed confirmation sheet to Physio: -By fax to: 1-866-448-9567 -By email to: [email protected] -Or by mail to: Physio-Control, Inc. P.O. Box 97006, Dept. 15N Redmond, WA, 98073-9706. Customers with questions call the firm at 1-800-442-1142, option 7, 6:00 A.M. to 4:00 P.M. (PST), Monday Friday.

    Distribution

    Worldwide Distribution-US ( nationwide) in states of: AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TX, VA, WA, WI, and WV and countries of: Australia, Brazil, Canada, Czech Republic, Denmark, Finland, France, French Guiana, Germany, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Qatar, Saudi Arabia, Slovenia, South Africa, Sweden, Turkey, United Arab Emirates, and United Kingdom.

    Quantity

    338 units total (US =139 units; International = 199 units)