Parker Waichman LLP is investigating potential lawsuits involving the HeartStart MRx Monitor/Defibrillator, manufactured by Philips Healthcare. Roughly 47,000 devices have been recalled in the United States due to electrical issues that may cause the device to malfunction. If this occurs, the system could fail to deliver life-saving therapy.
The HeartStart defibrillator provides electrical shocks to patients in cardiac arrest, or provides pacing in patients with an abnormally slow heartbeat. The U.S. Food and Drug Administration (FDA) gave the recall its most serious Class I designation. If you or someone you know suffered injury or death related to the recalled HeartStart external defibrillator, contact one of our experienced product liability attorneys today. Our firm continues to offer free, no-obligation case evaluations.
HeartStart Defibrillators Subject to Class I Recall Due to Electrical Issues In February 2017, Philips Healthcare notified customers of a recall affecting its HeartStart MRx Monitor/Defibrillator through an "Urgent Medical Device Correction". The device was recalled due to electrical issues that could cause the defibrillator to malfunction, failing to deliver life-saving electrical shocks or pacing.
The recalled device is an external defibrillator used by medical professionals trained in CPR. The system delivers electrical shocks to patients in cardiac arrest. In patients with an abnormally slow heart rhythm, the system provides pacing. The HeartStart contains electrodes, which are attached the patient’s chest. The machine then analyzes the patient’s heart rhythm to determine whether they are in cardiac arrest or need pacing.
According to a recall alert posted on the FDA website, the HeartStart MRx Monitor/Defibrillator was recalled because defects with electrical and battery connections may prevent the system from working as intended. The defibrillators may fail to power up, charge, and deliver electrical shocks or provide pacing. This can lead to serious, fatal consequences.
The recall affects the following model numbers, the notification states: M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, and M3536M9.
A total of 47,362 units in the United States are affected by the recall. The recalled products were manufactured between Feb. 11, 2004 and Nov. 4, 2016. The affected units were distributed between Feb. 12, 2004 and Nov. 4, 2016.
The recall notification states, that the recall is being initiated "due to electrical and battery connection issues that may prevent the device from powering up, charging, and delivering an electrical shock therapy. The device may also unexpectedly stop pacing. A delay in delivering therapy could result in serious patient injury such as permanent organ damage, brain injury, or death."
The FDA designated the recall as Class I, the agency’s most serious recall status. Class I recalls mean that exposure to the recalled device presents a reasonable risk of serious injury or death.
In its recall letter, Philips Healthcare instructed its customers to check the model number on their devices to see if they are affected by the recall. Customers are also advised to inspect the battery connector to ensure that "pins are clean, fully extended and free of residue", among other things.
The recall was initiated on Feb. 24, 2017.
Previous Warnings and Recalls for Philips AEDs
Philips has faced other issues in the past involving its defibrillators. In 2013, the FDA warned that some Philips HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite Automated External Defibrillators (AED) may fail to work in an emergency. The affected devices were manufactured between 2005 and 2012.
Previously, Philips had initiated a voluntary recall in September 2012 because an internal electrical component could fail. Subsequently, the defibrillator may mistakenly indicate that it is ready for use when it is not. Some 700,000 devices were affected by this recall. The company released updated information concerning the issue in November 2013.
"The FDA advises keeping all recalled HeartStart AEDs in service until you obtain a replacement from Philips Healthcare or another AED manufacturer, even if the device indicates it has detected an error during a self-test," said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health, according to a press release. "Despite current manufacturing and performance problems, the FDA considers the benefits of attempting to use an AED in a cardiac arrest emergency greater than the risk of not attempting to use the defibrillator."
The recalled AEDs were sold under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite.
The FDA designated the recall as Class 2, meaning that the recalled device can lead to temporary or medically reversible health problems or the risk of serious injury is rare. "In this current situation, the FDA believes that because the patients who need these devices are in a life threatening situation, the chance of serious adverse consequences or death directly related to AED failure is very difficult to conclusively determine," regulators noted in 2013.
The recalled AEDs can be used by first responders, including fire departments and Emergency Medical Services (EMS) workers. The life-saving devices can be used in the home, as well as public settings such as airports, community centers, schools, and government buildings.
According to the Wall Street Journal, roughly 47 percent of the affected defibrillators were sold in the United States. CBS News reported at the time that Philips was still trying to contact 22 percent of customers.
Home models of the Philips AED devices were first approved in 2004.
Philips also issued a voluntary recall for certain AED products in 2009. The worldwide recall affected certain HeartStart FR2+ AEDs. The recall was issued due to a possible memory chip defect that can cause the device to malfunction.
"The HeartStart FR2+ defibrillators are used by trained responders and designated response teams to help treat sudden cardiac arrest. The device automatically analyzes the heart rhythm and determines whether a defibrillation shock is needed. If a shockable rhythm is detected, the FR2+ instructs the responder to deliver defibrillation therapy," the company said in a press release.
"Philips has received reports of a memory chip failure in a small number of FR2+ units manufactured in 2007 and early 2008. These reported failures were detected during routine self tests, not during emergency use of the AED. Failure of this chip could render the AED inoperable and prevent it from delivering therapy when indicated, although Philips has received no reports of injury associated with this chip failure."
The recall affected a total of roughly 5,400 units worldwide. Only certain models were affected by the recall. The systems affected by the recall were distributed to fire departments, EMS, hospitals and other organizations.
In 2015, the company issued a Class 2 recall for its Philips HeartStart XL+ Defibrillator/Monitor due to "Multiple software and hardware issues with device that can affect its function." The FDA determined that the issue was caused by device design. Philips implemented an upgrade affecting both the hardware and the software. A total of 13,168 devices were affected.
Filing a Philips HeartStart External Defibrillator Lawsuit
Parker Waichman has years of experience representing clients in medical device and drug injury lawsuits. If you or someone you know is interested in filing a lawsuit involving the Philips Healthcare HeartStart MRx Defibrillator, contact one of our experienced product liability lawyers today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).