Online CPR Certification Blog
Defective electrical component in HeartStart Defibrillators causing malfunction
Date: March 4th, 2014
FDA recalls Philips defibrillators
According to the statement issued by FDA, some of these devices couldn’t deliver an electrical shock during a cardiac arrest situation. The regulator issued some recommendations in a safety advisory to have the devices inspected and also advised on the usage of recalled devices during an emergency situation, where necessary, says Steve Silverman, who is the director of FDA office of compliance at the Center for Devices and Radiological Health.
In a statement, he said that the FDA advises the public to keep all the recalled HeartStart AEDs serviced until Philips Healthcare or any other AED manufacturer provides you with a replacement even where the device indicates that an error has been detected during a self test. Despite the prevailing performance and manufacturing problems, FDA still considers the advantages of trying to use the AED during a cardiac arrest situation to be much greater than failing not to use a defibrillator in an emergency.
The devices recalled by FDA were those manufactured and distributed between 2005 and 2012 under various brand names, including HeartStart FRx, HeartStart OnSite HS1and HeartStart HS1. Consumers were advised to contact the parent company, Philips Healthcare for immediate replacement of their devices. This announcement follows the recall of three devices in September 2012 where 700000 units were affected. Just before the latest recall by FDA, Philips had sent their customers updated information regarding an internal electrical component that was defective and which made some of the units to fail.
External defibrillators help in saving lives
In the statement, FDA said that it would still continue with their duty of monitoring manufacturers as a way of ensuring that they provide quality system manufacturing and practices changes which facilitated the recent recalls. Every year, thousands of live are saved by using the automated external defibrillators when someone experiences a cardiac emergency. Even though the initial discovery was made back in 19th Century, the technology was tweaked by William Bennett Kouwenhoven in 1957 to create a device that shocked the patients without an open cavity surgery and the device was immediately adopted by Johns Hopkins Hospital as a first line standard treatment for cases of cardiac arrest.
However, operating these devices required the users to undergo through some training. But in the recent years, untrained responders have been using the external defibrillator even a random passerby who use these devices that are placed strategically to save the life of someone. Unlike the manual defibrillators, the automated ones only require very little instruction to use. Strategic placement of these devices by businesses and consumers contributes greatly to saving life during a heart attack. Even a layperson is able successfully jumpstart the heart of the patient as they wait for emergency health care. Statistics show that in America, more than 300000 people experience a cardiac arrest.