HM Government

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Press release: Faulty defibrillator: users urged to check battery connection

People and organisations should check if they have the defibrillator model, LIFEPAK 1000 Automatic External Defibrillators (AED), because a technical fault with some of them means they may not deliver an electric shock to the heart to someone who is in cardiac arrest.

This issue could potentially affect all LIFEPAK 1000 devices. There are 10,068 devices in the UK.

These devices are available in public places such as schools, airports, football stadiums and leisure centres. They are often known as public access defibrillators (PAD) as they are intended to be used by anyone. They are also found in hospitals, clinics and ambulances. The manufacturer’s logo on the front cover may vary, displaying ‘Medtronic’ or ‘Physio-Control’.

The manufacturer, Physio-Control, has sent a safety alert to people with affected defibrillators with instructions for action. If you have not received an FSN from the manufacturer, please contact them directly. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a Medical Device Alert.

The fault is due to intermittent connection between the battery and device contacts because of wear and subsequent corrosion between both components. This could fail to deliver a shock to resuscitate a patient.

It is important that the manufacturer’s instructions are followed by completing and returning the confirmation sheet immediately.

People should check that the serial number listed in their confirmation sheet matches the serial number on the label located on the back of the device.

If your device powers off unexpectedly, either during inspection or during patient treatment, immediately remove and reinstall your existing battery to restore power to the device. If power is not restored, replace the battery with a spare battery and call Physio-Control immediately to arrange for servicing of your device.

It is important to implement a weekly schedule of battery removal and reinstallation for all LIFEPAK 1000 devices until contacted by Physio‐Control to arrange repair for any affected devices. Removing and reinstalling the battery on a weekly basis will help make sure your device is ready for use. It is also important to always carry a fully charged spare battery.

As part of the maintenance and testing schedule, users of the LIFEPAK 1000 Defibrillator should always follow the Operating Instructions which direct users to routinely inspect both the battery well and battery contacts, especially if the devices have been exposed to vibrations or the battery has been installed for an extended period without being removed.

John Wilkinson, MHRA’s Director of Medical Devices said:

These devices deliver life-saving treatment and it is vital they operate correctly when needed in an emergency.

People who are responsible for them should carry out the checks recommended by the manufacturer.

If you have any questions please contact Physio-Control on 0808 258 0094.

Notes to Editor

  1. View the Medical Device Alert

  2. View the Field Safety Notice.

  3. Customer support for Physio-Control: 0808 258 0094, option 4, 08:30 – 17:00, Monday – Friday

  4. For more information on the manufacturer please visit their website

  5. Report any problems with medical devices to us via the Yellow Card Scheme

  6. MHRA is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). MHRA is an executive agency of the Department of Health.

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HM Government

Press release: Helen Stephenson CBE will be the next chief executive of the Charity Commission

Helen Stephenson, who has been Director of Early Years and Childcare at the Department for Education since 2014, will join the Commission on 18 July. She succeeds Paula Sussex in the role.

Helen has extensive experience of senior leadership across the public and voluntary sectors, having previously served as Director and Deputy Director of the Office for Civil Society, and has filled senior roles at the Big Lottery Fund and the Shaftesbury Society. She has also, until recently, been chair and trustee of the National Childbirth Trust, and was part of the Advisory Council of the National Council for Voluntary Organisations.

In her current role, Helen leads a large team in delivering and implementing a multi-million pound childcare programme, and was responsible for taking the Childcare Act through Parliament. At the Cabinet Office, Helen’s responsibilities included delivering government policy on charities, social action and volunteering, social investment and the National Citizens Service.

Helen Stephenson said:

The charitable sector plays a crucial role in our national life and I am delighted to be joining the Charity Commission at this important time. It is an honour to be leading the dedicated and talented team at the Commission and Paula is handing over an organisation that is in excellent shape, well equipped to meet the challenges of the future. I look forward to working with the Commission’s staff to continue the ambitious plans we have set.

William Shawcross, Chairman of the Charity Commission, said:

It is wonderful that Helen is joining us. The board and I are confident that she will be an outstanding leader and will build on the progress we have made in recent years. I know our excellent staff will give Helen a warm welcome and I look forward to working with her.

Helen Stephenson – career

2014-2017 Director of Early Years and Childcare, Department for Education

2011-2014 Director, Office for Civil Society and Government innovation Group

2007-2011 Deputy Director, Office for Civil Society, Cabinet Office

2004-2007 Head of Strategic Policy and Partnerships, the Big Lottery Fund

2001-2004 Senior Policy Advisor, New Opportunities Fund/ Big Lottery Fund

Helen Stephenson – voluntary experience

2014-2017 NCVO Advisory Council 2015-2017 Trustee and Chair, National Childbirth Trust 2013-2017 Board Member, Big Society Trust

Honours

2014 – CBE for services to Civil Society in the Birthday Honours list

Ends.

PR 41/17

Notes to editors

  1. The Charity Commission is the independent regulator of charities in England and Wales.
  2. To find out more about our work, see our annual report.
  3. Search for charities on our online register.
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HM Government

News story: Review of legislation update

The SSRO has sent an update to consultation respondents on its review of the regulatory framework.

The regulatory framework for single source defence contracts came fully into effect in December 2014. It controls the prices of qualifying contracts and requires transparency on the part of defence contractors regarding their prices and capacity to continue to meet government requirements.

The Secretary of State is required to complete periodic reviews of the framework, with the first review to be completed by December 2017. The SSRO’s functions include keeping the operation of the framework under review and making such recommendations for change to the Secretary of State as it considers appropriate. In carrying out a review, the Secretary of State must have regard to any recommendations made by the SSRO, provided these are submitted six months before the date on which the review is to be completed. This means that the SSRO has to make recommendations in June 2017 in order to meet the statutory deadline.

On 30 January 2017 the SSRO published a consultation which proposed a number of recommendations for the first review of the regulatory framework for single source defence contracts. The SSRO has focused its proposed recommendations for change on three key areas: ensuring that single source spending is appropriately covered by the regime; enhancing transparency; and providing effective enforcement of the regime. As part of our consultation, the SSRO also held meetings and workshops with key stakeholders.

Before reaching our final conclusions and publishing our recommendations in June 2017, the SSRO has today sent to consultation respondents an update on its review of the regulatory framework, outlining the feedback we have received from stakeholders and the progress made since the consultation closed on 24 March 2017.

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HM Government

News story: Osprey RIBs report and flyer published

Collision between RIBs Osprey and Osprey II in the Firth of Forth, Scotland resulting in serious injuries to one passenger

MAIBs report of the collision between the rigid inflatable boats (RIBs) Osprey and Osprey II resulting in serious injuries to one passenger in the Firth of Forth, Scotland on 19 July 2016 is now published.

The report contains details of what happened, subsequent actions taken, and recommendations made.

PDF, 4.25MB, 40 pages

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email maib@dft.gsi.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

MAIB statement:

The Marine Accident Investigation Branch has investigated several accidents in which people have been injured as a result of inappropriate seating on RIBs.

The message is clear: There are currently no regulations preventing persons on RIBs from sitting on the inflatable tubes. Passengers not sitting on suitable inboard seating have an increased risk of falling overboard, are at significant risk of musculoskeletal injuries and, as demonstrated by this accident, are exposed to serious injury in the event of a collision. The faster the RIB, the greater the risk.

As a consequence, we have today recommended the Maritime and Coastguard Agency to include in its forthcoming Recreational Craft Code that the certified maximum number of passengers carried on commercially operated passenger carrying RIBs should be limited to the number of suitable seats designated for passengers. We have also made a recommendation to the Royal Yachting Association aimed at improving the guidance available to the operators of commercial passenger carrying RIBs.

A safety flyer for the small commercial vessel industry summarising the accident and detailing the safety lessons learned has also been produced and is contained as an annex to the report. The flyer can be viewed and downloaded as a separate document here.

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HM Government