Prevention of Future Deaths reports · 2023

Karlton Donaghey

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 report23 Oct 2023
Reference2023-0399
DeceasedKarlton Donaghey
CoronerJames Thompson
Coroner areaNewcastle upon Tyne and North Tyneside
CategoryChild Death (from 2015) · Product related deaths
Sourcejudiciary.uk record · original PDF
Responses published1

The report

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

Responses

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.

Response from Product Safety and Standards (PDF)
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

Related reports

Other reports by James Thompson

See all →

More reports categorised “Child Death (from 2015)”

See all →

Track Child Death (from 2015)

See every Prevention of Future Deaths report matching Child Death (from 2015), and how often a new one appears.

What would an alert for this have sent me? Search the full text

Free to try — the preview shows the real matches and how many arrived in the last 12 months. Your first email alert is free.

These reports are published by the Chief Coroner's office at judiciary.uk and are © Crown copyright. The text here is reproduced from the published PDF so it can be searched. If something on this page is wrong, or you are a person named in it and want it reviewed, email drcjar@gmail.com and we will act promptly.