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December 20, 2013

Philips Clarifies HeartStart AED Advisory

aed GraphicMany of our readers may have seen a Safety Communication from the Food and Drug Administration (FDA) on December 3, 2013 about the Philips HeartStart AED. This was actually old news for Philips customers, as it pertains to a 2012 safety notification and Class II recall of the HeartStart FRx, HeartStart Home, and HeartStart OnSite Automated External Defibrillators (AEDs), due to the remote possibility of electrical failure with a component.

This was not a recall of all devices.

So why the new communication from the FDA? Our Philips representative sent us a customer communication that outlines the events as follows:

If anything is wrong with any of the AED’s internal components, the device’s self-test will alert the AED owner by emitting a pattern of triple chirps. If you hear this alert from your Philips AED, it is your cue to call Philips for technical support. In the U.S., that number is 1.800.263.3342.

    • On October 24, 2013, the FDA asked Philips to issue another letter to follow up on the original Customer Information Letter out of concern that not enough U.S. customers were reached by the original mailing. The revised customer letter mailed in the U.S. in November, 2013 seeks to reinforce Philips’ earlier message: if your device triple chirps, call Philips for technical support.
    • The FDA often classifies customer communications as a “recall” even though the notification is not intended to retrieve products.
    • The revised letter was labeled as a safety notification because the FDA wanted our customers to pay attention to the information in the letter. Philips has not changed its original message that was, and is, intended to remind customers to call Philips for technical support upon hearing a pattern of triple chirps.
    • The FDA sent out a press release and posted another communication on its website in approximate conjunction with Philips’ recent revised letter to ensure that the Philips communication to U.S. customers was read and understood.
    • The FDA updated the communications on its website to parallel Philips’ own safety notification. The revised communications from the FDA explain that there is no need to replace your AED unless the device triple chirps, indicating a problem was detected during the AED’s self-test.

For more information regarding this action, please visit the Philips’ website at www.philips.com/heartstartmaintenanceadvisory, or contact Philips for technical support at 1.800.263.3342, and select option 5.

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