BEUDAMED
    FDA Recall Terminated

    LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LP15 monitor/defibrillator is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. 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-0863-2019 · Initiated February 1, 2019

    Recall

    Recall Number
    Z-0863-2019
    Event Number
    81939
    Firm
    Physio-Control Inc
    FEI Number
    3015876
    Product Code
    MKJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 1, 2019
    Posted
    February 26, 2019
    Terminated
    April 18, 2024
    Address
    11811 Willows Rd Ne, Redmond, WA, 98052-2003

    Description

    LIFEPAK 15 Monitor/Defibrillator service kits Product Usage: The LIFEPAK(R) 15 Monitor/defibrillator (LP15) is a complete acute cardiac care response system designed for basic life support (BLS) and advanced life support (ALS) patient management protocols. The LP15 monitor/defibrillator is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions specified in the Operating Instructions. The LP15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. 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

    Certain LIFEPAK 15 Monitors/ Defibrillators were reported to experience a lockup condition after a shock was delivered. This condition is defined as a blank monitor display with LED lights on, indicating power on the device, but no response in keypad and device functions.

    Action

    Stryker sent an Urgent Medical Device Safety Notice & Correction Action Required letter dated February 1, 2019 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter requested customers. Review the attached impacted device list. Go to www.strykeremergencycare.com/fa281response to provide Stryker verification of the status of the devices listed. Upon confirmation of your device status, a member of our field service personnel will contact you to arrange for the correction of your device. The devices subject to this field action are planned to be serviced by December 31, 2019. If you have questions regarding this matter contact Customer Support team by calling 1 800 442 1142 and selecting option 7.

    Distribution

    Worldwide Distribution

    Quantity

    682 kits