Philips Healthcare's External Defibrillator Gets a Class 1 RecallMar 29, 2017
The U.S. Food and Drug Administration (FDA) just announced a Philips Healthcare's product recall of an external monitor and defibrillator. The FDA has categorized the action as a Class 1 recall, which is the agency's most serious designation and involves "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."
The HeartStart MRx Monitor/Defibrillator is intended for use by medical professionals who are trained in CPR. Cardiopulmonary resuscitation (CPR) is the manual application of chest compressions and ventilations to patients in cardiac arrest. CPR is conducted in an effort to maintain life until advanced help arrives.
This recall affects 47,362 devices manufactured and distributed between 2004 and 2016. The issues concern the HeartStart MRx Monitor/Defibrillator. The battery and electrical connection issues in the device that are used to pace patients with bradycardia (slow heart rate) or are meant to shock patients with sudden cardiac arrest, may stop the device from charging, powering up, and delivering electrical shock therapy, according to a MedWatch report.
The FDA wrote that the device may also stop pacing and its use may result in severe injuries such as permanent organ damage, brain injury, or death.
The product liability attorneys at Parker Waichman LLP have extensive experience representing consumers in lawsuits over allegedly defective or dangerous medical device. The firm continues to offer free legal consultations to individuals with questions about filing a Phillips Healthcare's external monitor and defibrillator lawsuit.
In February 2017, Philips Healthcare distributed a notice to customers, informing them to check the device's model number, inspect the battery connector pins, and contact the company for further support and information.
Prior Adverse Events Involving HeartStart Devices
"The FDA has received 1,100 complaints regarding the devices and 580 adverse event reports," reported Jennifer Rodriguez, a spokeswoman for the FDA. The Wall Street Journal and Ms. Rodriguez report that the HeartStart AED "has been linked to hundreds of adverse events."
At the time, Philips initiated a recall of the HeartStart AED (automated external defibrillator) in September 2012 that was deemed a Class II recall. Of the 700,000 products, according to Philips, nearly half of the AEDs were located in the United States.
How the External Defibrillator Works
An automated external defibrillator is a portable device that checks the heart rhythm and sends an electric shock to the heart to try to restore the heart to a normal rhythm. AEDs are also used to treat sudden cardiac arrest (SCA).
SCA is a condition in which the heart suddenly and unexpectedly stops beating. In this case, blood stops flowing to the brain and other vital organs. SCA usually causes death if not treated within minutes. Each minute of SCA leads to a 10 percent reduction in survival, according to the National Heart, Lung, and Blood Institute (NHIBI).
The heart has an internal electrical system that controls the rate and rhythm of the heartbeat. With each heartbeat, an electrical signal spreads from the top of the heart to the bottom of the heart. As the signal travels, it causes the heart to contract and pump blood. The process repeats with each new heartbeat.
Problems that may cause abnormal heart rhythms called arrhythmias, may cause the heart to beat too fast (tachycardia), too slow (brachycardia), or with an irregular rhythm. Some arrhythmias may cause the heart to stop pumping blood to the body and lead to SCA. The most common cause of SCA is an arrhythmia called ventricular fibrillation. In this case, the ventricles (the heart's lower chambers) do not beat normally, but quiver very rapidly and irregularly. Another arrhythmia that may lead to SCA is ventricular tachycardia. This is a fast, regular beating of the ventricles that may last for only a few seconds or for much longer.
In individuals who have either of these arrhythmias, an electric shock from an AED may restore the heart's normal rhythm. AED's are lightweight, battery-operated devices. Electrodes are attached to the patient and then connected to the device to help the device analyze a patient's heart rhythm. The electrodes deliver an electrical shock to restore a normal heart rhythm during sudden cardiac arrest, or to pace the heart to a normal rate.
AEDs are often found in places with large numbers of people, including shopping malls, businesses, airports, airplanes, and schools.
Have You Been Injured by a Philips Healthcare's External Defibrillator?
If you or someone you know has sustained injury associated with an allegedly defective medical device, you may be eligible for valuable compensation. The Parker Waichman personal injury law firm has handled many cases involving a broad spectrum of medical devices, including external defibrillators. The firm offers free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).