FDA Safety Communication for Philips AEDs

 

In response to the "FDA News Release" issued Dec 3, 2013, regarding the "detection of error" in Philips AED devices, we have just completed a conference call from Philips Canada and here are the facts.

 

1) All Philips AED's "self test" daily.  The self test consists of internally checking:

i) power 

ii) battery capacity 

iii) pad integrity 

iv)  ECG interpretation module

 

If there is a failure of that self test, the AED will "beep/churp" in the follow algorhythm:

 

A) a continuous single beep/churp to notify the site coordinator to press the blue "i" button on the AED.  Once the blue "i" button is depressed, the voice prompt will indicate the issue. For example, "change battery" or "change pads".  Once these accessories are replaced the AED until can be put back in service. 

 

B) A "triple beep/churp" indicates hardware failure of the AED and it must be taken out of service immediately.  Once removed from service please notify us and Philips will guarantee replacement.   If the triple beep/churp happens during use at a sudden cardiac arrest event, it is to be taken out of service and CPR is to be immediately continued. There has been some Philips AED units in the USA only (not Canada) that have "triple beep/churped" which equate to 0.05% of the Global marketplace.  The likelihood of a "triple beep/churp" occurring during use at a sudden cardiac arrest is highly remote. 

 

2) FDA has NOT recalled any Philip AED devices. It is frankly a "safety communication" to notify sites of the possible self-test (beep/churp) error that may occur. 

 

3) Health Canada has NOT issued a safety communication nor recall for any Philips AED devices.

 

4) We at Respond Solutions do address these self-test checks in all our AED training programs.  It is the responsibility of the sites where these AEDs are placed, to ensure the AED is in working order on a daily basis.  This visually consists of confirming a "flashing green" light is illuminating in its "self check" window. There is no other checks required for the AED. However, if the AED is "beeping/churping" , it is the responsibility of the site to notify Respond Solutions so we may assist in rectifying the error caught by the daily self-test.

 

5) Respond Solutions Inc databases all sites and AED's deployed by us to our Client's.  This database reports automated expiry dates on batteries and pads, so we may avoid any AED failure issues.  

 

We trust that this up to date information has satisfied your concerns.  We are diligent to keep you updated on any AED safety concerns brought forth by Health Canada or our partners abroad.  If you have any questions please contact me anytime.