FDA Alerts

Alert: Philips HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite Automated External Defibrillators (AED)

The FDA is alerting all users of the Philips HeartStart FRx, HS1 Home and HS1 OnSite AEDs manufactured between 2005 and 2012 that these devices may fail to deliver a shock in the event of an emergency.

Tue Dec 03 2013By Kaylee McCaffrey

Audience:

  • First responders who use Philips HeartStart FRx AED
  • Consumers who have purchased Philips HeartStart HS1 Home or HeartStart HS1 OnSite AEDs

Medical Specialty: Cardiology, Electrophysiology, Internal Medicine, Family Medicine

Device:
An automated external defibrillator (AED) is a device that analyzes the heart rhythm in victims of sudden cardiac arrest, and delivers an electrical shock to restore normal rhythm.

The Philips HeartStart FRx AED may be used by first responders including Emergency Medical Services (EMS) and fire departments.

The Philips HeartStart HS1 Home AED may be used in the home.

The Philips HeartStart HS1 OnSite AED may be used in public locations including airports, community centers, schools and government buildings.

Purpose: 
The FDA is alerting all users of the Philips HeartStart FRx, HS1 Home and HS1 OnSite AEDs manufactured between 2005 and 2012 that these devices may fail to deliver a shock in the event of an emergency.

Summary of Problem and Scope:
In September 2012, Philips Healthcare initiated a Voluntary Medical Device Recall of HeartStart Frx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs after determining that an internal electrical component in the AED could fail, and the device could incorrectly indicate it is ready for use. This recall affects approximately 700,000 devices.

In a Medical Device Safety Notice dated Nov. 19, 2013, Philips provided customers with updated information about the failure of an electrical component that could cause the AEDs to fail to deliver appropriate shock. The notification also directed consumers to a Maintenance Advisory disclaimer icon.

Recommendations:
Please be aware that the Philips HeartStart AEDs are designed to automatically test themselves at regular intervals to ensure they are ready for use. The HeartStart AED should emit a triple chirp sound and have a flashing “i-button” if it detects a serious problem that could prevent the HeartStart AED from delivering an electrical shock.

If your Philips HeartStart AED has ever emitted or begins to emit a pattern of triple chirps, please contact Philips Healthcare immediately at 1-800-263-3342, and select option 5 for technical support. Live technical support is available Monday – Friday, 7:00 am – 5:00 pm Pacific Time.

  • Keep the recalled HeartStart AED in service until Philips Healthcare replaces the device or you can obtain another working AED. Despite current manufacturing and performance problems, the FDA considers the benefits of attempting to use an AED in a cardiac arrest emergency greater than the risk of not attempting to use the defibrillator. 

If your Philips HeartStart AED is emitting a series of triple chirps during an emergency situation, and you are unable to locate another working AED:

1. Call Emergency Medical Services (EMS) or 911 and start cardiopulmonary resuscitation (CPR)
2. Press the flashing “i-button” and follow the voice prompts.
3. If there is an error message, remove and reinsert the battery to attempt to clear some errors and equip the device to deliver an electrical shock if needed. (Note: This step should be followed ONLY during an emergency situation.)
4. If an advised electrical shock is not delivered, continue CPR while you wait for EMS.
5. After the emergency is resolved, contact Philips Healthcare for a replacement unit.

 

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