Starting from 1 January 2022, safety alerts related to medical devices listed under MDACS that have potential serious health risk/ public health risk to local population are listed below.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Philips HS1/OnSite/Home AED pads [PN: M5071A (adult), M5072A (infant/child)] [HKMD No.:100129].
According to MHRA, the manufacturer has been identified in the Philips M5071A (adult) and M5072A (infant/child) AED pads that could pose a risk for patients or users. The affected products have been observed to experience gel separation from the foam/tin backing when peeled from the yellow plastic liner. The 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. Any pad currently installed in or stored with an HS1/OnSite/Home AED could experience this problem, and it is not possible to know prior to patient use if your pad is affected because the pads are protected by a foil seal. The manufacturer has received 115 complaints about this issue since 2010 (of which 84 complaints were received in 2021) for a total of approximately 5 million shipments of the affected products. Users should continue to use the HS1/OnSite/Home AED and pads as-is, and follow the voice prompts because the AED will step the user through the necessary actions.
For further information, please visit https://mhra-gov.filecamp.com/s/xdIJOYvVbpguk8zl/d
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 Mar 2022