Philips is notifying customers of a potential issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite).
Philips has identified that for affected pads, some gel may fold onto itself, resulting in reduced surface area of gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad to make contact with a patient’s skin.
If this occurs, the HS1 AED could deliver less effective or ineffective therapy. As affected pads are stored in sealed cartridges, this issue will not be visible until the cartridge is opened for use. Users should continue to use the HS1 AED and pads as-is and follow the device’s voice prompts during use. The AED will audibly guide users through each step of the procedure. It is recommended that customers and users keep their HS1 AED in service according to the Instructions for Use/Owner’s Urgent Medical Device Correction Letter/Field Safety Notice.
Philips is actively working on design changes to eliminate this issue in the Adult SMART Pads Cartridge and the Infant/Child SMART Pads Cartridge, and projects new pad availability later in 2022. Affected customers will be notified when the new design pad is available. This issue only relates to HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite), and does not involve HeartStart FRx.