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On February 23, 2022, Philips informed the FDA of a Medical Device Correction related to pads on the HeartStart OnSite AED. A small percentage (less than 0.01%) of pads for the HeartStart OnSite have been found to have a gel-separation defect that can impair use of pads during a rescue attempt. This potential defect is not tied to any specific lot numbers, meaning it may affect any OnSite adult or pediatric pads.
Based on the rarity of this defect, Philips and the FDA recommend that all OnSite AEDs remain in service. In fact, Philips will continue to ship new AED pads using their current manufacturing methods for the next several months so that AED equipment can be kept current until a remedy is available.
Philips has developed a new manufacturing method to eliminate the possibility of this defect, and the new method has been submitted to the FDA for review and approval. Once approved, Philips will provide updated pads for all late-model OnSite AEDs.
No action is required at this time, and all affected AEDs should remain in use. AED123 will ensure our customers receive updated pads when they are available.
Our team is here to answer any questions and to support you with all of your AED needs. Don’t hesitate to call us at 833-AED-1231 or contact us through the form on this page.
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