How often have you passed a device hanging on a wall in an office building, a mall or an airport, that has a sign such as the one pictured here or a similar signage telling you that this device is available to use so you might save someone’s life if their heart goes into an abnormal rhythm?
If you are still wondering what an AED is, our friends at Wikipedia provide this information:
An automated external defibrillator or AED is a portable electronic device that automatically diagnoses the potentially life threatening cardiac arrhythmias of ventricular fibrillation and ventricular tachycardia in a patient, and is able to treat them through defibrillation, the application of electrical therapy which stops the arrhythmia, allowing the heart to reestablish an effective rhythm.
Well – that’s what they are supposed to do! Turns out, there are a whole lot of these devices out there that are simply defective.
On July 19, 2010, Cardiac Science Corporation, considered a global leader in automated external defibrillator (AED devices), announced their plan to replace 24,000 defective AED devices in the United States. This comes after significant FDA pressure that began in November 2009.
The FDA first published a MedWatch Safety Alert following multiple complaints of devices failing to deliver electric shocks in emergency situations, and also failing to internally detect a device failure/problem during routine safety checks. The FDA then followed in March 2010 by issuing a formal Class I recall followed by an expanded scope in April 2010. A Class I recall is the most serious public notice and applies to devices that have a reasonable probability of malfunctioning and causing serious adverse health consequences.
The product models involved include Cardiac Science Powerheart, CardioVive, Nihon Kohden, and the GE Responder External Defibrillator manufactured between August 2003 and August 2009. The FDA has listed the specific models involved on their website.
At present time, 24,000 AED devices in the US will likely not work if needed in an emergency situation as defined by a Class I recall. The FDA reported the devices may fail to deliver shocks; fail to identify life threatening ECG rhythms needing shock delivery; fail to identify lead placement problems; fail to filter background noise that may interfere with ECG analysis and delivery of a shock.
Four months after the FDA Class I recall notice, on July 19, Cardiac Science Corporation detailed their plan to replace the 24,000 devices. While no specific time frame was detailed in the public statement, a priority based plan to repair or replace the defective devices was presented. Devices issued to police, fire, and ambulance services will be addressed first. Once this is accomplished, hospitals, medical clinics, dialysis centers, and assisted living facilities will be addressed next. According to the FDA, Cardiac Science will be responsible for contacting all users and setting a replacement schedule. However, there is no plan to replace devices that were issued into the general public domain. Instead, public purchasers of any listed defective products need to contact the company or go online (www.cardiacscience.com/aed175) or call (877-941-0844, reference ID4331134) to receive an updated software component. Cardiac Science urges the public to replace the software as soon as possible.
Non-USA purchased devices for first responders, hospitals, clinics, dialysis centers, assisted living facilities, and general customers will also only receive the software replacement. The company boasts distribution of products in over 100 countries.
The FDA recommends that all users not listed in the priority replacement plan including home users, public access defibrillation programs, and facilities with only one AED device do the following:
- Obtain and install the software components as soon as possible. The FDA cautions, the software upgrades may not detect some failures. However, still try to use the device as the unit may likely be able to deliver the necessary therapy.
- If the device indicates service is needed, then contact the company to repair or replace the device. Use an alternative AED device in the meantime.
In the 4th paragraph of their public statement, Cardiac Science listed the impact on earnings. The company estimates spending $28.5 to $33.5 million dollars over the next 12 months. They have extended the company line of credit to fund the recall, so the public and investors can be reassured of the company’s ability to manage the recall.
The FDA urges all who experience any problems with AED devices to report the problems promptly through their online MedWatch, Safety Information and Adverse Reporting program. Be sure to include the make, model, and serial number of the device; the initial and final condition of the patient; and a description of the device problem. Healthcare providers should follow their institutional policy/procedure for FDA reporting.
The public should have major concerns about shopping malls, airports, planes, and trains, etc. that rely on these devices. Persons in these settings usually are less trained and less experienced in using such devices. In all likelihood, they would be less likely then first responders to know what to do in an emergency situation with a defective malfunctioning device. Based on the press release, the company has not issued new training guidelines. This recall has also not been picked-up by the national/international media, so how will global general users know a major recall is in process? Spread the word. Ask your building manager if they are aware of the recall and have them check their AED and confirm whether or not it is on the recall list of these devices.
It is simply mind-boggling how it has taken so long for this information to get out and how long it took for the recall to be made. Whatever the price, these devices need to be corrected or removed without any further delay!