Mitica Marin

Association of Ambulance Chief Executives 
Metal Box Factory (GG322) 
30 Great Guildford Street 
London 
SE1 0HS 

T:  

E:  

W:  www.aace.org.uk 

13 May 2020 

BY EMAIL:  

Mr Grahame Irvine 
Area Coroner 
East London Coroners 

Dear Mr Irvine 

REGULATION 28 REPORT – ACTION TO PREVENT FUTURE DEATHS:  MITICA MARIN 

I am writing in response to the Regulation 28 report to prevent future deaths following the inquest 
into the death of Mitica Marin which you issued on 12 March 2020 to 
Association of Ambulance Chief Executives (AACE).  

, the 

AACE is a private company owned by the English Ambulance NHS Trusts. It exists to provide 
ambulance services with a central organisation that supports, coordinates and implements 
nationally agreed policy. Our primary focus is the ongoing development of the English ambulance 
services and the improvement of patient care. We are a company owned by NHS organisations 
and possess the intellectual property rights of the JRCALC UK ambulance service clinical practice 
guidelines. AACE is not constituted to mandate or instruct ambulance service however we do 
have national influence via the regular meetings of ambulance Chief Executives and Trust Chairs 
along with a network of national specialist sub-groups. 

I am responding as managing director of AACE on behalf of 
read your report and considered the concerns you have raised.  I can confirm that we are very 
aware of the need for prompt defibrillation if this is indicated for a patient in cardiac arrest.  

 our chairman. I have 

Last year we undertook an extensive review of the resuscitation sections of our clinical practice 
guidelines. We considered the issue of using manual or automatic mode for delivering the first 
shock in a cardiac arrest situation and we issued our revised guidance to the UK ambulance 
services in June 2019. The section of our guidance pertaining to manual or automatic mode is 
detailed below: 

Most manual defibrillators carried in ambulances can also be used in an AED 
mode where they analyse the ECG and recommend delivery of a shock when 
appropriate. There are advantages and disadvantages of each mode. Although 
AED mode may improve the time to first shock, manual mode may reduce pre-
shock pauses and increase chest compression fraction which is associated with 
increased ROSC. Therefore, although manual defibrillation should be the 
preferred option for appropriately trained paramedics it should be recognised that 
solo responders are potentially in a stressful environment, and are attempting to 
manage multiple complex factors. Therefore, the initial use of the AED function is 
acceptable until additional help arrives. 

Chairman:  

Managing Director:  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 In summary of the above extract, we are advocating that a defibrillator can be used in automatic 
mode if a solo responder arrives on scene first. 

We are aware that there are a number of types of defibrillators in use in UK ambulance service, 
however, it is not our responsibility as a membership organisation to decide or recommend which 
device an ambulance service should purchase. 

I hope that you will agree that we have responded to the concerns that you have raised. We can 
assure you that we are absolutely committed to learning from all adverse events and doing everything 
within our power to prevent them happening again in the future. 

If we may be of further assistance, please do not hesitate to contact us.  

We would like to extend our sincere condolences to the family of Mitica Marin. 

Yours sincerely 

Managing Director 

Chairman:  

Managing Director:

From Nadine Dorries MP 
Minister of State for Patient Safety, 
Suicide Prevention and Mental Health 

39 Victoria Street 
London 
SW1H 0EU 

03 June 2020 

Your Ref: 
Our Ref: 

Mr Graeme Irvine 
HM Area Coroner, East London 
Coroners Court 
Queens Road 
London E17 8QP 

Dear Mr Irvine 

Thank you for your letter of 12 March 2020 to Matt Hancock about the death of Mitica 
Marin.  I am replying as Minister with responsibility for patient safety and I am grateful for 
the additional time in which to do so.  

Please extend my most sincere condolences to Mr Marin’s family and loved ones.  I 
appreciate how distressing Mr Marin’s sudden death must be to those who knew and loved 
him and we must do all we can to take the learnings from his death to prevent future 
deaths. 

Your report explains that in a review of cases of delayed defibrillation conducted by the 
London Ambulance Service, a contributing factor was that the LIFEPAK 15 monitor and 
defibrillator was defaulted to manual mode, requiring the user to select the automatic 
external defibrillator (AED) mode when desired.  You ask if future deaths could be avoided 
if the LIFEPAK 15 device was defaulted to the AED setting.  

In preparing this response, my officials have taken advice from NHS England and NHS 
Improvement (NHSEI), the Medicines and Healthcare products Regulatory Agency 
(MHRA), the Association of Ambulance Chief Executives (AACE) and the London 
Ambulance Service.  

The MHRA advises that it has not received any similar reports regarding the default 
settings of this model of defibrillator.  Factory default settings have to cover a wide range 
of applications and are not suitable for all purposes.  The LIFEPAK 15, used in hospitals 
and by ambulance staff, may be set up with different default settings, based on the 
intended use, for example as a clinical monitoring tool or an AED.  Information on different 
set up options is provided with the device.   

Professional organisations are best placed to determine the appropriate default settings 
according to their local protocols and intended use, taking into account available guidance.   

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     
 
 
 
 You will know from the AACE’s response to your report that in 2019, as part of a review of 
clinical practice guidelines, the advantages and disadvantages of manual and automatic 
modes for delivering the first shock to patients in cardiac arrest were considered.  As a 
result, revised guidance was issued in June 2019 that acknowledged that while manual 
mode may be the preferred option for trained paramedics, the automatic mode may be 
preferable in other situations, for example, solo first responders in potentially stressful 
environments.    

I am advised that the London Ambulance Service provides training to clinical staff on the 
importance of prompt defibrillation and, in October 2019, issued updated cardiac care 
guidance for staff making clear that in all cases of cardiac arrest, the LIFEPAK 15 should 
initially be switched to AED mode.      

I understand that the London Ambulance Service has considered if changing the default 
setting of the LIFEPAK 15 to AED mode could improve clinical outcomes.  The London 
Ambulance Service has decided, for reasons set out in its response to your report, that this 
is not practical for every-day use given the device’s functionality as both a clinical 
monitoring tool and defibrillator.     

In relation to future procurement of defibrillators, this is a matter for individual ambulance 
services.  I am advised that the London Ambulance Service is looking to source devices 
that have in-built technology to negate the need for the user to actively select the mode of 
operation.  I understand that such a device has not been located but that, where it can, the 
London Ambulance Service is encouraging manufacturers to consider this functional 
requirement for future models.   

In the absence of such a design, it is of course important that ambulance services using 
devices such as the LIFEPAK 15 look to mitigate the risk of future incidents of delayed 
defibrillation and my officials have asked the AACE to make the concerns in your report 
known to ambulance services in England.  I note the measures taken by the London 
Ambulance Service, including updated guidance to staff on managing cardiac arrest, 
human factors training and focused training for solo first responders.      

Finally, my officials have drawn this matter to the attention of the MHRA and also 
Professor 
, the National Clinical Director for Heart Disease at NHSEI.  
Following discussion with clinical colleagues, Professor 
default mode of the device being manual, rather than automatic, is acceptable having 
considered the rationale of the London Ambulance Service deliberations on this matter.  
Professor 
 has recommended that, if further monitoring and analysis of data shows 
continuing evidence of delays, consideration should be given to changing the default 
setting of the device and this advice has been shared with the London Ambulance Service. 

 has advised that the current 

I hope this response is helpful.  Thank you for bringing these concerns to my attention.   

NADINE DORRIES

NHS)

London Ambulance Service
NHS Trust

Legal Services

Headquarters
Mr Graeme Irvine 220 Waterloo Road
London
HM Area Coroner for East London SE1 8SD
Walthamstow Coroner’s Court Tel:
Queens Road Fax: 0207 783 2009
London www.londonambulance.nhs.uk
E17 8QP
28 April 2020
Dear Sir

Regulation 28; Prevention of Future Deaths Report (PFD) arising from the inquest into the death of Mitica

MARIN

Thank you for your Regulation 28 Report dated 12th March 2020 setting out your recommendations for
consideration.

| would like to begin by expressing my sincere condolences to the family of Mr Marin.

| will address the matters set out in the PFD report, as directed to the London Ambulance Service NHS Trust
(LAS) as follows:

Delay in defibrillation of Mr Marin

It was accepted in evidence heard at the inquest that Paramedic A did not recognise, in a prompt manner, that
Mr Marin was in ventricular fibrillation (VF) (a cardiac rhythm that may respond to defibrillation) and thus a
defibrillation shock was not delivered immediately.

A serious incident investigation was undertaken into the circumstances that gave rise to this incident. The
investigation found two causative factors were that Paramedic A, having attached Mr Marin to the Lifepak 15
defibrillator (LP15 defibrillator), did not then look at the screen of the LP15 defibrillator to observe the rhythm
displaced and as such did not observer the VF and thus did not charge the LP15 defibrillator and deliver a shock
in manual mode. Further, Paramedic A did not turn the LP15 defibrillator into automatic external defibrillator
mode (AED) which would have initiated an audio and visual prompt to cease chest compressions and stand
clear while the LP15 defibrillator analysed the rhythm and charged.

The investigation found the factors contributing to this omission were that this was Paramedic A’s first shift as
a solo responder and the significant stressors of managing a busy and emotionally charged environment, as the
only clinician on scene in the initial stages. Paramedic A gave evidence that she focused on specifically coaching
those present to assist with chest compressions and this caused her to become distracted from the LP15
defibrillator.

Page 1 of 5

Paramedic A spoke in evidence of her immediate reflective practice and learning, which was supported by her
clinical managers, and was able to demonstrate how that was able to put it into action just a few days later
when managing another patient in cardiac arrest.

Paramedic A described how undergoing this reflection and further training has helped reinforce the importance
of her training on the order of priorities when managing a patient in cardiac arrest, in a busy and emotional
setting when working as a solo responder.

When asked what she would do differently going forward, Paramedic A cited the importance of putting the
LP15 defibrillator into AED mode as a priority and the focus being on defibrillation, as the training for
paramedics and ambulance crews sets out.

Paramedic A cited the training actions the LAS had undertaken around the fundamental importance of prompt
defibrillation, where clinically indicated. In addition to this, the LAS has produced clinical update material to
mandate that on all cardiac arrests the LP15 defibrillator should initially be placed in AED mode.

A comprehensive update bulletin ‘Cardiac Care Guidance’ dated 28" October 2019 was produced to this effect,
attached for reference.

This has also been incorporated this into the core skills refresher (CSR) training which all clinical staff undergo
in the LAS.

LAS thematic analysis of delayed defibrillation

It was also recognised that the delay in defibrillation of Mr Marin was not an isolated incident for the Trust. In
order to address incidents of delayed defibrillation, the LAS undertook a review of similar cases and completed
a thematic analysis report in December 2019. The updated Action Plan from this report is attached for your
reference.

It is worth noting that the LAS aim to download data from defibrillators and analyse this to improve the care of
patients in cardiac arrest. It is through this practice that the LAS have often been able to detect any delay in
defibrillation. We would caution any comparison of LAS practice against organisation who do not undertake
such audits.

The thematic analysis found that a contributing factor to the circumstances where the LP15 defibrillator is not
put into AED mode was that the LP15 defibrillator model defaults to manual mode before use. It is therefore
necessary for the user to deliberately put the LP15 defibrillator into AED mode when the circumstances
indicate.

You heard live evidence from two LAS staff, the Clinical Practice Development Manager Critical Care, who
provided a clinical opinion and also spoke in part to the thematic analysis. You also heard from a Quality,
Governance and Assurance Manager who provided evidence on the serious incident investigation, findings,
individual reflection and learning and wider Trust learning as well as speaking on the details of the thematic
analysis, action plan to continue work to mitigate the risks of not only the circumstances that gave rise to the
delay when treating Mr Marin, but taking into account other contributory factors.

Page 2 of 5

Can the LP15 defibrillator be set to AED mode as a default?

You asked the question whether, if the LP15 defibrillator were to be set to automatic mode by default it would
mitigate the risk of a delayed defibrillation, particularly in the circumstances that arose during the resuscitation
of Mr Marin.

Our Clinical Practice Development Manager gave evidence setting out that it was technically possible for the
LP15 defibrillator to be set to AED mode as default, which would require the user to actively have to switch it
off when managing a patient who did not require defibrillation. He went on to explain that this option has been
considered by the Trust’s medical directorate but the evidence gathered in consideration of the best option to
mitigate against clinicians being distracted and/or overwhelmed managing multiple tasks at a busy scene,
indicates that to set the LP15 defibrillator to AED mode as default was not overtly practical for day to day use.

He cited the rationale that the LP15 defibrillator in the pre-hospital setting is used not only for defibrillation but
as a multi parameter patient monitor including oxygen saturations, blood pressure and ECG and as such is used
in this function many times per day by ambulance crews. These functions cannot be used in the main when the
LP15 defibrillator is in AED mode. If the machine defaulted, when turned on, to AED mode it would issue a
verbal prompt to attach the defibrillation pads and analysis of the rhythm.

The LAS has sought the advice of colleagues worldwide as the benefit of this potential change it was felt given
the numerous times a shift the monitor is used as a routine clinical assessment tool, it would simply become a
matter of ‘muscle memory’ that the monitor is turned from AED mode to manual mode. It was felt that
unintended consequences of such a change would be in what are the comparably rare circumstances of a
cardiac arrest we would find the ambulance clinicians turning the monitor to manual mode as this is what they
would do on every other occasion it is used.

Further to this the LAS is minded of the potential to heighten patient anxiety by the verbal prompts when the
monitor is turned on in routine circumstances. We would like to provide assurance that the LAS has considered
this decision in some detail and assessed the potential benefits and consequences of such a change.

Mitigating the risks of delayed defibrillation — what are the LAS doing?

Taking forward the actions identified in the SI report for Mr Marin together with the Trust wide actions
detailed in the thematic analysis, evidence was provided on the following:

Continuing to identify risks

The Trust have taken significant steps in downloading our LP15 defibrillator data and this is one way that we
are able to identify incidents of delay in defibrillation. The Trust set its own target of 20% which we exceeded
and as such we increased it to 30%. We are currently on track at around 23%. We are attempting to lead the
way with ambulance trusts in respect of these download figures and probably more importantly being able to
review this data, but this is a work in progress that we are always seeking to improve.

There is a further review planned to build on the finding of this thematic analysis and to monitor the
effectiveness of the actions that were identified and put into practice. We will be aiming to update our findings
based on the continuing evidence we are collating. At this point in time we are unable to commit to a fixed
timescale for this, in light of the severe pressures the Trust is currently managing due to the unprecedented
demand, in relation to the COVID-19 pandemic response, which will certainly be ongoing for some time.

Page 3 of 5

As a Trust we are proud of our instances of incident reporting, including self-reporting. This has improved
significantly in recent years and the Trust has focused on providing a supportive environment to identify
lessons and learn, both individually (as evidenced by Paramedic A, who self-reported the incident) and as an
organisation.

Practical measures

From August 2019 large yellow indicators (stickers) with ‘push analyse for AED mode’ were placed on LP15
defibrillators to act as an alert reminder to users to switch the machine into AED mode. This was
communicated to staff via station management as well an update in our Routine Information Bulletin (RIB)
which is emailed to all staff and also available on the intranet. We have also sought to ensure that devices used
in training reflect this change.

Training

There is an ongoing focus on training and communications with staff. Paramedic A spoke to this effect in her
evidence that bulletins, intranet communication, emails and clinical updates in our RIB are a good source of
refresher training.

This training has also been reiterated in our core skills refresher (mandatory) training program, which runs
quarterly for all operational staff. CSR 2019.2 and 2019.3 included refresher training on resuscitation including
AED mode and order of priorities on scene.

Our Quality, Governance & Assurance Manager explained in evidence that training now includes clear and
unambiguous priorities to be undertaken at a cardiac arrest thus aiming to reduce the opportunity for errors in
this first few minutes in managing a cardiac arrest. This has focused on ensuring that by having clear priorities
the ‘mental bandwidth’ of the clinicians is maximised to ensure they can more effectively deal with the
challenges they are presented with on scene.

Human Factors Training

Further to the evidence you heard in respect of training, in addition the LAS is continuing to progress ‘human
factors training’ to focus on optimising staff performance through better understanding of behavioural
interactions with each other and the environment. This is especially pertinent for operational staff who deal
with chaotic, emotional scenes and where no two scenes are the same.

We have started to train clinical education and standard tutors to enable them to train front line staff through
CSR program, to ensure human factors are included in the key messages. To date, five members of staff have
attended a ‘Train the Trainer’ program for human factors which involved them taking a lead role in being able
to apply the principles to investigations and education programs.

In particular, at each of our ‘Train the Trainer’ sessions for the CSR program, we ensure human factors training
is included in the key messages so it is addressed by tutors at each session. We included a particular model to
help with communications at scene which was included in our CSR 2017 module.

A further six staff are due to undertake the ‘Train the Trainer’ program. We also have a full day of training in
areas specific to human factors (communication, active listening, speaking up as part of a team, and how
bandwidth impacts decisions and communications) which we hope to be in a position to roll out in July/August

Page 4 of 5

2020 for all tutors and a large number of clinical team managers and advanced paramedic practitioners. This
timescale will be kept under review, given the ongoing pressures that the Trust is currently facing.

Procurement of defibrillators

Your report also requests that | address the matter of procurement decisions regarding the future supply of
defibrillators.

Efforts are being made to investigate devices which have in-built technology to potentially bypass the need for
a clinician to have to remember to put the device in AED mode (for example, a device that would automatically
switch the device to AED mode when defibrillator pads were applied). At this point in time, we have not
located a specific device on the market with this functionality which is also sufficiently robust for the
ambulance market.

The available options for procurement of defibrillators will continue to be reviewed as part of the processes for
tender for procurement of clinical equipment. Where we have such contacts as one of the world’s largest users
of defibrillators we have encouraged manufactures to consider such options in future development.

Finally, | very much hope this response helps in setting out the ongoing work that the LAS are engaged with to
ensure staff are fully up date and trained in the importance of AED mode and defibrillation as the priority and
the ongoing work to further develop and monitor trust wide learning and communicate this to our staff.

We will continue to further our work following the thematic analysis in an ongoing effort to mitigate the risk of
delayed defibrillation. As always, we endeavour to contribute to national and international discussions to seek
out the best available options for equipment and welcome the consideration of our stakeholders to this
matter.

Yours sincerely J
fy

Chief Executive, London Ambulance Service NHS Trust

Page 5 of 5

Mr G Irvine 
Area Coroner 
Walthamstow Coroner’s Court 
Queen’s Road 
Walthamstow 
E17 8QP 

14 April 2020 

Dear Mr Irvine, 

Ref 

The Resuscitation Council UK has reviewed and discussed the recommendation made in the Regulation 
28 Report dated 12 March 2020.  

Although defibrillators can be set to start up in either automatic or manual mode, the latter is preferred. 
This is because when used correctly, studies have shown that a manual mode results in greater chance 
of return of spontaneous circulation and subsequent survival to hospital discharge, compared with an 
automatic mode. Manual defibrillation is therefore recommended for advanced life support, as delivered 
by ambulance paramedics. 

We are concerned, therefore, that recommending start-up in an automatic mode may actually worsen 
overall outcome. The resuscitation standards expected of ambulance paramedics are to deliver manual 
defibrillation and we would support the remedial actions taken by LAS in relation to local training, 
labelling and guidelines to ensure appropriate resuscitation practice is safely and effectively applied in 
future cardiac arrests. 

We hope you find this information useful. 

Yours sincerely, 

Professor 

Honorary Treasurer RCUK 

resus.org.uk 
enquiries@resus.org.uk 

5th Floor, Tavistock House North 
Tavistock Square, London WC1H 9HR 
Registered Charity Number 1168914

Regional Counsel 
Stryker House 
Hambridge Rd, Newbury 
Berkshire, RG14 5AW 

October 30, 2020 

Mr. Graham Irvine 
Area Coroner 
Walthamstow Coroner’s Court 
Queens Road, Walthamstow, E17 8QP 

By email: 

Dear Mr. Irvine, 

Regulation 28 Report, March 12, 2020, REF: 

I write in relation to the Regulation 28 Report to Prevent Future Deaths dated March 12, 2020, REF: 
issued by the Walthamstow Coroner’s Court (the “Report”).  

, 

Please be advised that Physio-Control was acquired in 2016 by Stryker Corporation, and that the LP15 device 
is distributed in the UK by Stryker UK Ltd (“Stryker”). Accordingly, this response is made by Stryker on behalf 
of Physio-Control UK Ltd. 

A copy of the Report was sent to Stryker’s Newbury offices, however, it was not provided to me until after the 
response deadline of May 7, 2020. This delay was in part caused by reduced onsite staffing measures taken by 
Stryker to ensure the safety of  its employees during the ongoing COVID-19 pandemic. We regret this delay, 
and the corresponding delay in our substantive response to the matters raised in the Report. 

In  part,  the  Report  concludes  that  “If  the  LP15  defaulted  to  automatic  mode  or  on  start-up  required,  the 
choice of manual or automatic mode it is possible that such delays could be avoided.” 

After consultation with the manufacturer of the LP15 device, I can advise that the LP15 monitor/defibrillator 
is designed with the ability to be configured to power on in either automatic or manual defibrillation mode 
based  on  the  clinical  protocols  of  the  health  system.  Accordingly,  I  respectfully  submit  that  the  Coroner’s 
Concerns listed at Section 5 of the Report do not accurately reflect the capabilities of the LP15 device.  

Stryker  requests  that  appropriate  adjustments  be  made  to  both  paragraph  4  (commencing  “This  is  not  an 
isolated incident,…”) and paragraph 7 (commencing “If the LP15…”) to accurately reflect that the LP15 device 
can  be  configured  to  power  on  in  either  automatic  or  manual  defibrillation  mode  based  on  the  clinical 
protocols of the health system using the device. 

Due  to  the  existing  capability  of  the  LP15  to  be  configured  to  power  on  in  either  automatic  or  manual 
defibrillation mode, Stryker does not propose to take any action in relation to the Report. 

Finally,  to  date,  Stryker  has  not  received  a  copy  of  any  responses  from  interested  parties  to  the  Report. 
Pursuant to r29 (6) of the Coroners (Investigations) Regulations 2013, I request that a copy of any responses 
received to the Report be provided to me using the contact details above (email preferred). 

Should you have any questions in relation to this letter, do not hesitate to contact me. 

Yours sincerely, 

Stryker UK & Ireland