Consent Decree

Philips Defibrillator Consent Decree

What is a Consent Decree?
A consent decree is a court order issued by a federal judge with terms agreed to in advance by the U.S. government and the defendants. A consent decree typically includes injunctive provisions ordering that the defendants take or refrain from taking certain actions, with the defendants subject to court-imposed sanctions if they fail to do so.
Why did the DOJ and FDA seek this Consent Decree from Philips?

The government sought a Consent Decree from Philips due to issues raised by regulators primarily concerning Emergency Care & Resuscitation (ECR) manufacturing practices at our Andover, Massachusetts and Bothell, Washington sites. The Decree includes provisions covering other Patient Care & Monitoring Solutions (PCMS) businesses at these two facilities.

 

In those inspections, FDA communicated its concerns regarding Philips' compliance with the Good Manufacturing Practices (GMP) requirements of the Food Drug and Cosmetic Act, focusing on how Philips addressed quality issues with specific components of Philips defibrillators (including the R92 resistor).

What Philips businesses are affected by this action?

The immediate effect of the Consent Decree is that the Emergency Care & Resuscitation (ECR) business is to suspend shipping and manufacturing all of its products, including its defibrillator products, until the FDA determines that ECR complies with the Agency’s quality systems regulation.

 

The decree also includes quality system compliance provisions for medical devices produced by other Patient Care & Monitoring Solutions (PCMS) businesses at these two facilities. Philips will continue to manufacture and distribute these other PCMS devices. Medical devices and consumer products manufactured by other Philips businesses at these facilities are not affected by the decree.

 

Philips is committed to full compliance with the terms of the Consent Decree, and to fulfilling all necessary conditions to resume manufacture and shipping of affected products.

What is the impact of the Consent Decree on Philips manufacturing and shipping of defibrillator products?

The immediate effect of the Consent Decree is that the Emergency Care & Resuscitation (ECR) business is to suspend shipping and manufacturing all of its products, including its defibrillator products, until the FDA determines that ECR complies with the Agency’s quality systems regulation.

 

At this time, under the terms of the Consent Decree and subject to limitations and conditions, Philips is permitted to continue manufacture and shipping of HeartStart Home and HeartStart OnSite automated external defibrillators in order to meet public health needs.

 

Under certain conditions, Philips may also manufacture and ship Philips HeartStart FR3 devices to customers who have standardized on HeartStart FR3 devices.

 

Additionally, the company may continue to provide necessary consumables and accessories for Philips defibrillator products, without restriction.

 

As noted in the terms of the Consent Decree, Philips may continue to service and upgrade existing devices, as well as continue R&D efforts and participation in clinical trials.

 

Our focus remains on rapidly and effectively returning Philips’ defibrillator manufacturing sites to consistent compliance with quality regulations, as we renew our culture of quality.

Are the Philips devices subject to this action safe to use?

It is important to understand that Philips defibrillators and other products manufactured by the affected business remain in use by customers, have strong reliability records and should not be taken out of service.

 

For perspective, with respect to the product issue that FDA focused on most intently in its most recent inspections of the Bothell facility – a component in our pre-2013 FRx and HS1 AEDs – out of 650,000 Philips AEDs with this component shipped before 2013, and an estimated 45,000 uses on patients, we are aware of approximately 12 instances in which the device failed to deliver all indicated shocks while in use on patients. Moreover, in all these cases, the AED still delivered at least one shock.

 

Additionally, Philips HeartStart public access AEDs shipped since January 2013 have a reliability record of approximately 99.9% per year.

What Philips products are affected by this injunction?

All Philips HeartStart defibrillator products are affected by this injunction, with specific exceptions as noted in the Consent Decree.

 

At this time, subject to limitations and conditions, Philips is permitted to continue manufacture and shipping of HeartStart Home and HeartStart OnSite automated external defibrillators in order to meet public health needs.

 

Under certain conditions, Philips may also manufacture and ship Philips HeartStart FR3 Automated External Defibrillators (AEDs) to customers who have standardized on HeartStart FR3 devices.

 

Philips may continue to provide necessary consumables and accessories for Philips defibrillator products, without restriction.

 

Philips may continue to service and upgrade existing devices, as well as continue R&D efforts and participation in clinical trials.

 

Our focus remains on rapidly and effectively returning Philips’ defibrillator manufacturing sites to consistent compliance with quality regulations, as we renew our culture of quality.

Will Philips be issuing recalls and replacements for any or all devices subject to this Consent Decree?
As stated in the terms of the consent decree, Philips is required to issue customer notifications for a number of specified products.
Are there any steps for your customers to take related to this Consent Decree? Should they not be using affected devices? Are they safe to continue to use?

It is important to understand that Philips products manufactured by the affected business remain in use by customers, have strong reliability records and should not be taken out of service.

 

For perspective, with respect to the product issue that FDA focused on most intently in its most recent inspections of the Bothell facility – a component in our pre-2013 FRx and HS1 AEDs – out of 650,000 Philips AEDs with this component shipped before 2013, and an estimated 45,000 uses on patients, we are aware of approximately 12 instances in which the device failed to deliver all indicated shocks while in use on patients. Moreover, in all these cases, the AED still delivered at least one shock.

 

Also, Philips HeartStart public access AEDs shipped since January 2013 have a reliability record of approximately 99.9% per year.

 

At this time, under the terms of the Consent Decree and subject to limitations and conditions, Philips is permitted to continue manufacture and shipping of HeartStart Home and HeartStart OnSite automated external defibrillators in order to meet public health needs.

 

Under certain conditions, Philips may also manufacture and ship Philips HeartStart FR3 Automated External Defibrillators (AEDs) to customers who have standardized on the HeartStart FR3 device.

 

Additionally, the company may continue to provide necessary consumables and accessories for Philips defibrillator products, without restriction.

 

Per the terms of the Consent Decree, Philips may be required to notify customers concerning specific requirements, updates, or other pertinent information regarding a limited number of specified products.

What help or resources are you providing your customers with affected devices?

Per the terms of the Consent Decree, Philips may be required to notify customers concerning specific requirements, and other pertinent information regarding a few designated products.

 

Philips remains committed to providing our customers with all necessary services and support.

Who are your major customers for the affected devices?

Philips advanced life support monitor/defibrillators are used by hospitals and Emergency Medical Services (EMS) providers.

 

Philips automatic external defibrillators (AEDs) are used in clinical settings, by public safety organizations such as fire and police departments, and in public access AED deployments in environments such as airports, schools, office buildings, airlines, and the home.

 

At this time, under the terms of the Consent Decree and subject to limitations and conditions, Philips is permitted to continue manufacture and shipping of HeartStart Home and HeartStart OnSite automated external defibrillators in order to meet public health needs.

 

Under certain conditions, Philips may also manufacture and ship Philips HeartStart FR3 Automated External Defibrillators (AEDs) to customers who have standardized on the HeartStart FR3 device.

 

Additionally, the company may continue to provide necessary consumables and accessories for Philips defibrillator products, without restriction.

Has there been any increase in the number of complaints with your devices within the affected businesses, whether for performance or safety?

No. As we have made continued investments in product quality and reliability, we have seen decreases in complaint rates and an increase in reliability.

 

As the world's leading supplier of defibrillators, Philips products in the area demonstrate strong reliability.

 

It is important to understand that Philips products manufactured by the affected business remain in use by customers, have strong reliability records and should not be taken out of service.

 

For perspective, with respect to the product issue that FDA focused on most intently in its most recent inspections of the Bothell facility – a component in our pre-2013 FRx and HS1 AEDs – out of 650,000 Philips AEDs with this component shipped before 2013, and an estimated 45,000 uses on patients, we are aware of approximately 12 instances in which the device failed to deliver all indicated shocks while in use on patients. Moreover, in all these cases, the AED still delivered at least one shock.

 

Additionally, Philips HeartStart public access AEDs shipped since January 2013 have a reliability record of approximately 99.9% per year.

For how long will the Consent Decree be in place?

The Consent Decree will be in effect for a minimum of five years. We anticipate that resolving the Consent Decree related issues will take some time, as an effort to improve our compliance documentation, ensure a consistently compliant quality system, and engage in extensive third-party audits is an intensive and exacting process.

 

The specifics of timing and sequence of our defibrillator manufacturing and shipping returning online are subject to third-party input and validation, and we will address those questions when we have a clearer picture of the roadmap currently in development.

Customer inquiries

Please contact:

ecr.communications@philips.com

 

Contact Customer Care

Media inquiries

Please contact the Philips Group Press Office:

 

Mario Fante

mario.fante@philips.com

+1 (603) 560 - 9226

 

Steve Klink

steve.klink@philips.com

+ 31 6 108 888 24