Counterfeits and unbranded copies of LifeVac anti-choking devices may fail to work correctly or worsen choking incidents if used, DSI/2024/003
Anti-choking devices are intended to alleviate choking incidents after Basic Life Support protocols have been attempted and failed. There are numerous counterfeit and unbranded anti-choking devices being sold in the UK online which do not have a valid UKCA or CE mark and may pose a significant risk of worsening choking if used. These devices should not be used in the event of a choking emergency and should be disposed of once identified as counterfeit or non-compliant.
Device Details
Counterfeit and unbranded anti-choking devices appear similar in design to the LifeVac anti-choking device, and primarily originate from China. No genuine anti-choking devices marketed in the UK are manufactured in China, and therefore products shipped from China should be treated with significant suspicion.
Image comparison between genuine and counterfeit anti-choking devices is provided further below in this document.
Explanation of identified safety issue
The MHRA is aware of numerous unbranded and counterfeit anti-choking devices (also known as airway clearance devices, choking rescue devices, or emergency first aid devices) which do not comply with the requirements of the UK Medical Device Regulations 2002 (UK MDR 2002) being sold online via marketplaces and drop-shipping websites.
The MHRA is currently aware of only two anti-choking device brands, LifeVac and Dechoker, which have a valid UKCA or CE mark and are registered with the MHRA in accordance with the UK MDR 2002. Both of these brands are intended to be used only after established Basic Life Support protocols (back slaps, abdominal thrusts) have been attempted and failed. There is further information and guidance on anti-choking devices available.
The vast majority of counterfeit and unbranded anti-choking devices, primarily originating from China, appear similar or identical in design to the LifeVac anti-choking device and, in some cases, may claim to be this brand.
Use of a counterfeit or unbranded anti-choking device carries a significant risk of failure to work, and may even worsen the situation by further pushing obstructions down the airway passage due to their poor design and quality.
Product Comparison
Images have been provided in this document to help UK users determine if they have purchased a genuine anti-choking device or a counterfeited or unbranded copy. Key distinctions between a genuine and counterfeit device are highlighted.
Review the images in this document against your own product and follow the applicable actions outlined below.
Actions
Actions for users and customers
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Check that your anti-choking device is genuine using the provided guidance. Do not use the anti-choking device in the event of a choking emergency if you suspect that the device you have purchased is a counterfeit or unbranded copy of the legitimate LifeVac anti-choking device. This is because the device is not compliant with the UK Medical Device Regulations 2002 and therefore there is a significant risk the device may fail to work or even worsen the situation.
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If you identify one or more of the above indicators of a counterfeit or unbranded anti-choking device copy, however are not certain, the MHRA would recommend contacting the legal manufacturer LifeVac Europe Ltd. The manufacturer can verify the legitimacy of the purchased product against their records of authorised distributors and product serial numbers.
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The MHRA recommends that purchasers of counterfeit or unbranded anti-choking devices dispose of the device rather than returning the device to the seller due to the risk of resale.
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When purchasing anti-choking devices online we advise users to exercise caution. Ensure that you purchase only from reputable sellers; be particularly vigilant for sites using fake reviews to promote their product. Users may check that the device’s manufacturer is registered with the MHRA via our public access database. The MHRA recommends you also refer to our published guidance on buying medical devices for personal use.
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If you have previously used one of these counterfeit or unbranded anti-choking devices and it failed to work, please report the incident to LifeVac Europe Ltd and to the MHRA via our Yellow Card scheme website, providing information on where you purchased the device.
Actions for those working in care settings
- If anti-choking devices are deployed or available for use in your care provider, you should review these devices against the information provided above in this notice to determine whether these are counterfeits or unbranded devices.
- If these devices are found to be counterfeit or unbranded, the guidance in ‘actions for users and customers’ should be followed accordingly.
Actions for healthcare professionals, especially health visitors or those working with parents in the community
- There are specific reporting arrangements for healthcare professionals to follow in each region. Healthcare professionals should report incidents:
- in Scotland to Incident Reporting & Investigation Centre (IRIC) and their local incident recording system
- in Northern Ireland to the Northern Ireland Adverse Incident Centre and their local incident recording system
- in England and Wales to the Yellow Card scheme website or via the Yellow Card app
Both Scotland and Northern Ireland have arrangements in place to share this information with MHRA without delay. When filling in the form, please remember to state where the device was purchased from.
- When advising parents regarding infant first aid or CPR, if questions are raised concerning the use of anti-choking devices or it is made clear that they possess one, you should:
- reiterate the need to apply established Basic Life Support protocols first. The manufacturer’s instructions should clearly refer to this in genuine devices. If necessary, refer to MHRA guidance concerning anti-choking devices.
- ensure that they check their own devices against the information in this document to verify they do not possess a counterfeit or unbranded device. Advise parents to take relevant guidance from ‘actions for users and customers’ if they do.
Stakeholder engagement
The MHRA is continuing to work with online marketplaces to identify non-compliant listings as soon as possible and remove these products from sale. We are also working with them to prevent further listings from being made.
The MHRA has engaged with the following stakeholders in formulating the information:
NHS England
Northern Ireland Adverse Incident Centre
NHS Scotland – Incident Reporting & Investigation Centre
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Published 25 March 2024