FOI release

Freedom of Information request on information regarding defibrillators failing to shock (FOI 22/686)

Published 22 March 2023

FOI 22/686

31 May 2022

Dear

Thank you for your email, dated 05/05/22, where you requested information regarding defibrillators failing to shock and for access to the data we hold. As explained when we spoke on the phone, on 17/05/22, we cannot share the data and information regarding specific manufacturers is exempt from release under section 44 of Freedom of Information Act 2000, see below.

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.

However, we can provide the total number of incidents on our database under the category ‘defibrillators, non implantable’ for which the failure mode has been coded with the term ‘failure to deliver shock’, please see below.

Between 01/01/2019 and 28/05/2022, a total of 131 incidents involving external defibrillators that failed to shock have been reported. Please note that this number includes all brands of devices that fit under the ‘defibrillators, non implantable’ category. When considering this data, it is important to be aware of the following points:

• These numbers are accurate at the time of extraction from our database, on 28/05/2022. Changes in the numbers can occur if new information is submitted at a later date, for example.
• Some incidents reported from mid-April onwards might not have been input into our database yet. Thus, such incidents would not be included in the total number of incidents we indicated above.
• These incidents were coded with the term “failure to shock” by the reporter of the incident (manufacturer/healthcare professional/member of the public) or by the person at the MHRA that processes the incident when it arrives in our database. However, it is not possible to guarantee that the incidents were coded with the correct failure mode.
• A report of an adverse incident involving a medical device does not mean that the medical device caused the incident.
• These figures need to be interpreted with caution. Consideration must be given to the individual procedures being undertaken, the skill of the healthcare professional performing the procedure, and the individual patient conditions.
• The information we hold on our database is not a complete picture of all the device-related incidents that happen in healthcare, it is just a snapshot.
• Therefore, our data must not be used to make a judgement on the safety of a particular type of medical device or how likely it is to be involved in an adverse incident or an estimate of complication rates.
• Reports do not necessarily represent an individual patient. Multiple reports on the same issue might be submitted. Where possible, multiple reports for the same event are linked. However, as reporters are not required to complete all fields, we cannot always guarantee that every duplicate is linked.

Regarding your follow-up questions on 1) when it is appropriate to report incidents to us and what the process is; and 2) if crew user errors should be reported to the MHRA, please see below.

The Yellow Card scheme is run by the MHRA and it is the UK system for collecting and monitoring information on safety concerns such as suspected side effects or adverse incidents involving medicines and medical devices. It is thanks to these reports, that it is possible to best outline any side effects or complications experienced with a medical device or medicine, and take action to protect patient safety where appropriate.

We encourage anyone to report any adverse events to the MHRA via the Yellow Card scheme, even if the event happened during testing of a device, for example. Moreover, crew user errors should also be reported because it might indicate that there is insufficient training and/or unclear guidance to operate the device. If a trend is detected, this might lead to, for instance, updating the IFU, updating the training for healthcare professionals, or it might even lead to the redesign of the user interface. While manufacturers are obliged to report any adverse incidents involving their devices and submit their findings, patients and healthcare professionals can voluntarily submit a report and we strongly encourage it.

You can find further information on medical devices Yellow Card reporting on this page.

The Freedom of Information Act only entitles you to access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.

If you have a query about the information provided, please reply to this email.

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

Please remember to quote the reference number above in any future communications.

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 at:

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

Yours sincerely

MHRA Customer Experience Centre