FDA Class I Defibrillator Recall
On February 12, the United States Food and Drug Administration (FDA) issued notice of a Class I recall of Philips Electronics’ HeartStart MRx Defibrillator due to defects that may result in failure of the device. A Class I recall is the FDA’s most serious class of recall, meaning that use of the affected device could result in serious injury or death.
The recall involves defects in the device’s crucial Gas Discharge Tube (GDT), which recently had been discovered to contain micro cracks through which internal gases could escape, causing the GDT not to function properly. According to the FDA, this defect to the GDT creates the potential for an electric current surge to “cross the device's designated resistors, which will damage the resistors and prevent the device from working while in automated external defibrillator (AED) mode.”
The Philips HeartStart MRx Defibrillator is designed to assist patients with two different kinds of cardiac issues. First, the MRx has a feature that is used to increase the heart rate of patients suffering from a slow heart beat. Second, the MRx is designed to deploy a lifesaving shock to the hearts of individuals undergoing sudden cardiac arrest.
A failure of the device’s AED mode means that the device may not deliver the lifesaving shock to patients in need, making this a potentially lethal defect.
The Class I recall, which impacts Philips HeartStart MRx Defibrillators manufactured between September 22 and October 16, 2016, follows a “Medical Device Correction Notice” originally sent by Philips to potentially impacted customers in June 2017. At the time, Philips instructed all customers to perform an inventory to identify potentially affected products and to ensure that those devices were set to function in “Manual” rather than “AED” mode while Philips worked to make replacement parts available.
For a complete list of affected lot numbers, Click Here.
If you or a loved one has suffered serious harm as result of a defective medical device, the expert attorneys at TheLawFirm.com are standing by to help you explore your legal rights with a free consultation.
United States Food and Drug Administration Website