FOI release

FOI 21/127 - CTGs ArjoHuntleigh Yellow card reports

Published 24 March 2021

Thank you for your email of 02 February 2021 asking about MHRA Yellow Card reports on the Arjo Huntleigh Cardiotocograph Sonicaid FM 830 and Team 3 models.

We understand that you would like to know if we’ve received reports about this make and model of device, but unfortunately we cannot share that information with you because of the confidentiality clause of the regulations that we work under (see details below). We can only provide information about general types of devices, not named brands or models.

If you have safety concerns about Arjo Huntleigh Cardiotocograph Sonicaid FM 830 and Team 3 models, please report them to MHRA via Yellow Card: https://yellowcard.mhra.gov.uk/devices/?type=hcp

If you haven’t already done so, you may wish to contact the Medical Devices Safety Officer (MDSO) for your trust email: MDSO@gstt.nhs.uk as they might be able to use the MDSO network to ask if other trusts reported problems with this device. We need people to report issues with medical devices because this allows us to build up a picture of what is going on across the market as a whole. As we have a remit for the whole of the UK, reporting allows us to build up this picture.

When people report, we monitor the themes and trends based on the risk of the incidents that are occurring and take action when it’s needed, such as issuing a safety communication.

We also work with other healthcare bodies such as NHSEI to share data and will collaborate on safety messaging when there are bigger issues that need communicating.

The information you have asked for is exempt from disclosure under Section 44 of the Freedom of Information Act 2000 (FOIA) Section 44 – Prohibitions on disclosure: The release of information is exempt as its disclosure is prohibited by other legislation. In this case, section 237 of the Enterprise Act 2002 prohibits a public authority from releasing information which came to it in connection with the exercise of its functions, and which relates to the affairs of an individual or business.

The MHRA is satisfied that the information you have requested: • constitutes information which came to us in connection with the exercise of the Agency’s functions. The MHRA has a duty of consumer protection under the Consumer Protection Act 1987 which is listed as a specified function under Schedule 14 of the Enterprise Act 2002, and receives information while exercising consumer protection functions in its role as the regulator of medicines and healthcare products. • relates to the affairs of Arjo Huntleigh, a business which continues to exist.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for an internal review. It will be carried out by a senior member of the Agency who was not involved with the original decision. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted online: https://ico.org.uk/make-a-complaint/official-information-concerns-report/official-information-concern/ or by post:

Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF

Kind Regards,

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU