Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable pads applied to potential victims of SCA with the following symptoms: 1) Unresponsiveness 2) Absence of normal breathing The HeartStart FR3 is intended for adults and children over 55 pounds (25kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child s age or weight, do not delay treatment. Device not sterile and not implantable.

Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.

On 10/10/2018, Urgent Medical Device Recall notices, which include Field Safety Notices, were mailed via certified mail to U.S. customers. The recalling firm's Key Markets are responsible for distributing the letters outside of the U.S. Firm is asking customers to follow the Action to be Taken by Customer/User section of the Medical Device Correction Notification/Field Safety Notice: 1) Identify the AEDs affected by this Field Safety Notice by checking the serial numbers. 2) You may continue to use your present device until a replacement AED is provided from the firm if you take precautions to prevent your device from being subjected to a pressurized water stream. 3) Please ensure that any owner or program manager of an affected device is promptly made aware of this notification. If you have transferred the device to another person, please forward a copy of this notice to that person and notify the recalling firm of this transfer as soon as possible. Customers with additional questions can call the following number for assistance: 1-800-263-3342 option 5