Consent Decree

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.