Philips Healthcare has updated its August 2012 safety notification for the HeartStart FRx, HS1 Home and HS1 OnSite Automated External Defibrillators (AEDs) in the U.S. in order to add information requested by the U.S. Food and Drug Administration (FDA).
Philips has cooperated with the FDA, and in November 2013, the company updated its original safety notification, further clarifying the AED user instructions directing users when to contact Philips for service in the event that the device emits an audible triple-chirp alert. These clarifications help ensure that users contact Philips in the event of a rare component failure that may lead the user to mistakenly believe that the cause of the triple-chirp alert has resolved itself and that it is unnecessary to contact Philips.
“Philips treats patient and operator safety as our primary concern, and we remain committed to the highest standards of product quality and compliance with government safety regulations for medical devices,” said Deborah DiSanzo, Chief Executive Officer of Philips Healthcare. “From the beginning, following our discovery of this potential but rare safety concern, we have been working closely with regulatory authorities and customers to address this issue, and we will continue to do so.”
Philips stands behind the quality of the HeartStart AED devices and will provide support to customers. Although the failure of this particular component is unlikely, it will be detected by the AED’s automated periodic self-test feature, which generates an audible triple-chirp alert to signal a customer to contact Philips immediately for service. Philips will provide the appropriate service and support to maintain the safety and efficacy of the device.
Philips’ HeartStart AED safety notification states that under extremely rare circumstances, an internal electrical component – a resistor – may fail when high voltage is applied, which in some cases may result in the inability of the AED to deliver a shock when needed. The safety notification affected approximately 605,000 HeartStart AEDs worldwide, of which 61 units have been returned for service or replacement due to this issue since the devices’ deployment between 2005 and 2012. Philips has not received any reports of patient harm due to this issue.
Calling Philips for technical support if the device has ever emitted or begins to emit a pattern of triple chirps is the only way to ascertain that the AED will be ready for use in an emergency. If an AED begins to emit a pattern of triple chirps during an emergency use, customers are advised to follow all voice instructions provided by the device. Once the emergency is resolved, Philips urges customers to contact their local Philips representative immediately.
To contact Philips regarding an affected device, customers may call their local service representative at 1-800-263-3342. For further information on how to identify the automated triple-chirp self-test alert, please visit: www.philips.com/heartstartmaintenanceadvisory.
The FDA safety notification regarding the can be found at: http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm376938.htm