安全通報 Philips AED HeartStart FRx, HS1 Home, HS1 OnSite

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

＊＊＊ 衛署醫器輸字第022831號 ＊＊＊   (登記為M5066A但商名為HS1)     the Philips HeartStart OnSite HS1

the Philips HeartStart FRx  未見QSD上有登記

HeartStart Home Defibrillator 未見QSD上有登記

Date Issued: Dec. 03, 2013
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 Advisory¹ .

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. 

該設備會定時自我檢測，如果設備有出現三聲喳喳喳(chirp)(我沒碰過，所以沒法形容,^_^),同時I-button也在閃爍時,表示設備己測到嚴重故障，請即與Philps連絡檢修。

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:如果您的AED己有上述情形，又沒有替代品時

1. Call Emergency Medical Services (EMS) or 911 and start cardiopulmonary resuscitation  (CPR) (先打119,持續作CPR)

2. Press the flashing "i-button" and follow the voice prompts.  (按下I-button鍵，並依語音操作)

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.) (若螢幕上有顯示錯誤訊息，請把電池拆下並重裝，再試看看是否可正常使用，如果己經在急救時，可以試電擊，看有沒有電擊能量輸出。)

4. If an advised electrical shock is not delivered, continue CPR while you wait for EMS. （如果仍無法電擊，持續作CPR待急救人員到達接手）

5. After the emergency is resolved, contact Philips Healthcare for a replacement unit. (事後請連絡Philips檢修設備)

FDA Actions The FDA continues to closely monitor all AED manufacturers' quality system design practices and device malfunctions that have persistently contributed to AED recall and Medical Device Reports.

In September 2012, the FDA classified Philips' recall of HeartStart AED devices as a Class II recall after determining that the chance of serious adverse consequences or death due the device failure is remote. In this current situation, the FDA believes that because the patients who need these devices are in a life threatening situation, the chance of serious adverse consequences or death directly related to AED failure is very difficult to conclusively determine.

In March 2013, the FDA issued a Proposed Order² requiring manufacturers of AEDS and accessories to submit premarket approval (PMA) applications. The FDA is currently reviewing and considering the comments provided by the public, and will take them into consideration when issuing a final order.

Reporting Problems to the FDAPrompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect that an AED has malfunctioned, the FDA encourages you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program³.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements⁴ should follow the reporting procedures established by their facilities.

Contact Information:If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at industry.devices@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.

Additional Resources:

• FDA press release⁵
• Philips Maintenance Advisory: HeartStart FRx and Onsite (HS1) AEDs ^{6 7}