Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2023-0399, written 23 Oct 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 23 Oct 2023 |
|---|---|
| Reference | 2023-0399 |
| Deceased | Karlton Donaghey |
| Coroner | James Thompson |
| Coroner area | Newcastle upon Tyne and North Tyneside |
| Category | Child Death (from 2015) · Product related deaths |
| Source | judiciary.uk record · original PDF |
| Responses published | 1 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
ANNEX A
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1)
NOTE: This form is to be used after an inquest.
REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO:
1. Office for Product Safety and Standards
Department for Business and Trade
1 CORONER
I am James Edward Thompson, HM Assistant Coroner, for the coroner
areas of Newcastle Upon Tyne and North Tyneside.
2 CORONER’S LEGAL POWERS
I make this report under paragraph 7, Schedule 5, of the Coroners and
Justice Act 2009 and regulations 28 and 29 of the Coroners
(Investigations) Regulations 2013.
3
INVESTIGATION and INQUEST
On 5th July 2022 an investigation was commenced into the death of
Karlton Noah DONAGHEY. An inquest into his death was opened on 7th
September 2023.
On 25th September 2023 I resumed and concluded an inquest into his
death.
I concluded that medical cause of death for Karlton was;
1a Diffuse hypoxic ischaemic encephalopathy
1b Asphyxia from a helium balloon accident (on 23/6/22)
1
4 CIRCUMSTANCES OF THE DEATH
Karlton was a 5 year old boy at the time of his death. He was made a
present of a large helium filled balloon at local fairground in the days
prior to his death.
On 23rd June 2022 whilst momentarily alone in his home he placed the
balloon over his head
He became quickly overcome by the helium and despite prompt rescue,
he suffered a hypoxic brain injury and subsequently died in hospital on
29th June 2022.
5 CORONER’S CONCERNS
During the course of the inquest the evidence revealed matters giving rise
to concern. In my opinion there is a risk that future deaths will occur
unless action is taken. In the circumstances it is my statutory duty to
report to you.
The MATTERS OF CONCERN are as follows. –
- the balloon which caused the death are freely available to purchase
without restriction, particularly at locations of places of entertainment for
children.
- Parents and those responsible for supervision of children are not fully
aware of the risks posed to young children of helium filled balloons.
- the balloon in question displayed no warning as to the potential risk to
young children
6 ACTION SHOULD BE TAKEN
In my opinion action should be taken to prevent future deaths and I
believe your organisation has the power to take such action.
2
7 YOUR RESPONSE
You are under a duty to respond to this report within 56 days of the date
of this report, namely by 18th December 2023. I, the coroner, may extend
the period.
Your response must contain details of action taken or proposed to be
taken, setting out the timetable for action. Otherwise you must explain
why no action is proposed.
8 COPIES and PUBLICATION
I have sent a copy of my report to the Chief Coroner and to the following
Interested Persons:
Karlton Donaghey’s Family
Public Health Department - Newcastle Upon Tyne City Council
I am also under a duty to send the Chief Coroner a copy of your response.
The Chief Coroner may publish either or both in a complete or redacted or
summary form. He may send a copy of this report to any person who he
believes may find it useful or of interest. You may make representations to
me, the coroner, at the time of your response, about the release or the
publication of your response by the Chief Coroner.
9
Assistant Coroner
23/10/2023
J.E THOMPSON
3
1 response published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
Office for Product Safety and Standards Cannon House 18 The Priory Queensway Birmingham B4 6BS James Edward Thompson HM Assistant Coroner Coroner's office Lower ground floor, Block 1, Civic Centre Barras Bridge Newcastle upon Tyne NE1 8QH Sent via email 18 December 2023 Dear Mr Thompson, Regulation 28: Prevention of Future Deaths Report Karlton Noah Donaghey Thank you for your Regulation 28 Report (Prevention of Future Deaths) dated 23 October 2023, following your investigation and inquest into the death of Karlton Noah Donaghey, who died on 29 June 2022 as a result of diffuse hypoxic ischaemic encephalopathy and asphyxia following a helium balloon accident. May I first say how sorry I was to hear of Karlton Donaghey's death. If you have the opportunity, please convey my deepest sympathy to his family. The Office for Product Safety and Standards (OPSS) is the UK’s national product regulator, responsible for the safety of all consumer products except food, vehicles and medicines. OPSS takes the safety of consumers, and in particular vulnerable consumers such as children, very seriously, and works alongside Local Authority Trading Standards to ensure that manufacturers, importers and distributers meet their obligations for product safety. I would like to set out the analysis we have undertaken which has indicated further steps we can take to seek to reduce the risk of such tragic events occurring in the future. Analysis UK law requires all consumer products to be safe. The Toys (Safety) Regulations 2011 (TSR) establishes essential safety requirements that toys must meet. Where there are any inherent risks or hazards associated with a toy, the Regulations require that warnings be provided on the product itself, and/or on the packaging or instructions. OPSS has considered the requirements in law and helium inhalation risks. Helium- filled balloons that are designed or intended for use in play by children are subject to the requirements established by the TSR, and we believe that helium inhalation is an inherent risk to children and is reasonably foreseeable. Those responsible for the safety of helium-filled balloons placed on the market in the UK therefore have an The Office for Product Safety and Standards (OPSS) delivers consumer protection and supports business confidence, productivity, and growth. It is part of the Department for Business and Trade. gov.uk/opss obligation to provide information and warnings about any helium inhalation risks of their products. This includes products supplied at fairgrounds whether as prizes or purchases. Where this is not the case, those manufacturing or supplying such products may be in breach of the law. While standards are voluntary they can be used by businesses to help demonstrate how they comply with the law. The government is able to ‘designate’ certain voluntary standards which, when followed by manufacturers of relevant products, confer on those products a rebuttable presumption of conformity with relevant regulations. Overriding this, as above, is the essential safety requirement that all toys placed on the market are safe when it is reasonably foreseeable that they are intended to be used by children. While designated standards can help manufacturers understand and meet their obligations in those regulations, the responsibility of safety rests with those who place toys on the market. OPSS has identified that the Toy Safety Standard EN71, which is currently designated, does not require warnings to be provided on helium- filled balloons about the risks of helium inhalation. Action OPSS will write to the British Standards Institution, as the UK’s national standards setting body, to recommend it considers updating the standard to reflect the risks of helium inhalation to children. OPSS has powers to restrict designated standards and we are considering placing a restriction on EN71 given the current absence of helium inhalation warnings. We would set out our rationale for this restriction with accompanying guidance aimed at ensuring compliance with the TSR. We will write to relevant trade organisations such the British Toy and Hobby Association and the British Retail Consortium to advise them of OPSS’ concerns about the risks posed by helium-filled balloons, and ask them to help ensure the industry is meeting its obligations in the TSR. We will also write to Local Authority Trading Standards authorities advising them of the risks from these products. I am grateful to you for bringing this matter to my attention. While nothing we can do can address the loss that Karlton’s family have experienced, I hope that this demonstrates the importance we place on protecting consumers, including children, from unsafe products. The actions we are taking are intended to help prevent the circumstances that tragically led to Karlton Donaghey’s death from happening in the future. I am copying this letter to Newcastle City Council Trading Standards. Yours, Chief Executive Office for Product Safety and Standards
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