THE INQUEST TOUCHING THE DEATH OF PATRICK NEIL WOODS Ref: 39895-2016 RESPONSE TO REGULATION 28 REPORTS TO PREVENT FUTURE DEATHS This document is filed on behalf of Draeger Medical UK Limited ("Draeger") , pursuant to regulation 29 of the Coroners (Investigations) Regulations 2013, in response to the reports dated 19 June 2017 served by Acting H.M. Senior Coroner for Bedfordshire and Luton following the inquest touching the death of Patrick Neil Woods.
2. The concerns expressed by the HM Coroner are: The evidence of some clinicians at the Inquest would suggest that the training was not effective; b There is a risk that clinicians: Do not identify that the Tiro is a machine that have not been trained on; ii_ Do not identify that the Tiro is any different to other machines that have been trained on;
iii. Forget the relevance of the COSY switch; iv_ Are not alert; in the absence of sufficient emphasis on the same, to the risk of delivering hypoxic mix; Are not aware, in the absence of a reminderlalert, that the Tiro is not functioning the clinicians think it should be functioning: busy they they how

3 Whilst the concerns are expressed in two separate documents, they are inter-related, since the desired result of addressing the concerns is that; in the future, all clinicians using a workstation such as the Tiro will know how to select the correct fresh gas path for the intended ventilation mode_ Draeger therefore responds to both PFD reports within this one document: Draeger recognises as a crucial priority the importance of optimising patient safety through optimising clinician competence regards the functionality of the machine. With those objectives in mind, Draeger has decided to take the following steps: The updating of its training documentation, which has already taken place; including: The Basic Skills Checklist which is and has been used in basic user training, and which the trainer and user must both specifically sign when completed. In addition to listing the skill for the selection of the external ACGO outlet, the Checklist now includes the demonstration of the correctlincorrect procedure for switching between external ACGO and manuallcontrolled ventilation, paying attention to monitored parameters and gas flow direction: The Workbook; which is and has been provided for self- guided use to be completed by the user, although a Draeger trainer can be on hand to offer advice. Pages 30-32 test the awareness of the machine can operate and include several boxes with yellow triangle warnings, which refer to the selection of the correct circuit and appropriate routing of the fresh gas, as well as the context for measurement of 02, pressure and volume
iii. The Quick Guide, which is and has been given to users who have training on the devices Page 8 shows the operation of how

the ACGO switch and now includes a box with yellow triangle warning, which refers to the risk of hypoxic gas mixture; iv The Practical Exercises, which have been intended for the user to do as part of the training package, now include five questions (out of a total of 23) intended to concentrate on the functionality of COSY and ACGO ventilation modes. The powerpoint presentation which had been intended for use by trainers now includes four slides devoted to the use of the COSY switch and the relevant ventilation modes_
vi. The Training Needs Analysis includes reference specifically to Ventilation Modes" and Operation of Auxiliary Common Gas Outlet b The circulation worldwide of Field Safety Notice ("FSN") to hospitals for circulation amongst their anaesthetic departments drawing attention to the principles applicable to re-breathing circuit systems Draeger will also send a copy of the FSN to electrical and biomedical engineering (EBME) bodies within each hospital within the UK to whom the FSN is sent. Draeger anticipates that the distribution of the FSN will begin October 2017. Draeger will follow up the circulation of its FSN within the UK by seeking confirmation of receipt: Having identified from its database all customers within the UK to whom a Fabius machine has been supplied, Draeger will take to contact all such customers for the purposes of arranging a site visit Draeger representatives within a 16 week period after the FSN to address any concerns raised and discuss any further training needs. from steps from

5_ In further pursuit of achieving the objectives identified above, Draeger intends also to take the following steps: Making a training video specifically to address use of the ACGO switch, for use in both introductory basic training and in refresher training sessions. b Continuous review of performance data and of all feedback from hospital and individual user information; Regular review at Competence Board level of such information; and 6_ Draeger would respectfully ask HM Coroner and HM Chief Coroner not to publish paragraph 5(d) above and or to redact paragraph 5(d) above when publishing this document The particular design , technical and commercial considerations are_ it is submitted, confidential. DAC Beachcroft LLP Solicitors_for Draeger 29 September 2017

Dear Mr Pears Regulation 28 Report to Prevent Future Deaths Court Reference 39895_ 2016 write in my capacity as Acting Chief Executive of Luton and Dunstable University Hospital NHS Foundation Trust ("the Trust" to address the concerns raised in the Prevention of Future Deaths Report issued following the inquest into the death of Mr Patrick Woods The matters of concern raised in the Report were:
1) The alarms on the equipment and monitors seemed to play no part in managing risk for the Anaesthetists
2) The AAGBI Guidance is quite specific, but time and again the witnesses said their practice was in effect contrary to the guidance_ It is unacceptable for such Guidance to be wilfully ignored
3) It was revealed that the factory setting for the Tiro for FiO2 was 18%. There seems to be agreement that this was not a safe setting, yet there were very few circumstances (mainly paediatrics) that the settings were changed. The Trust has now considered the above concerns in detail and reviewed the action to be taken to prevent future deaths_ On behalf of the Trust; set out the response below and would like to reiterate our sincere apology and condolences to the family and friends of the late Mr Patrick Woods_ Alarms_on anaesthetic equipmentlfactory settings anaesthetic machine and monitor is configured with default alarms by the manufacturer prior to delivery of the machine to the Trust As part of the commissioning of the machine, the settings of these default alarms are reviewed on behalf of the Trust by the Clinical Director for Anaesthetics to ensure are fit for purpose. Since this incident the default alarm settings have been discussed within the anaesthetic and operating department practitioners' forums, and the Trust has agreed a Trust default setting for each variable, which have been applied retrospectively to all machines currently in use from 21 July 2017 and will be applied prospectively to all future machines before are deployed for clinical use_ These Trust defaults will be reviewed annually by the Clinical Director for Anaesthetics to ensure that remain consistent with latest guidance , and provide safe alarm protection for all parameters. ncirnno": Simon Linnett Luton and Dunstable University Hospital VCL iet Executive: Pauline Philip NkS Foundaticn Trust NHS UCL Medical ShooiCunic: Leacning Hosolia: Acting Kerry Every they they they

The agreed default settings are as follows: Fio2 30% 100% ETCO2
3.0 -7.0 kPa Respiratory rate <8 breathslmin Pulse 45 120 beatslmin Blood Pressure Systolic 80 150 mmHg Mean 60 125 mmHg Oxygen Saturations 94 100% The default alarm settings have been agreed by the anaesthetists and operating department practitioners as providing acceptable safety for the majority of elective adult patients who are fit and well We have highlighted this fact in our communication with anaesthetists and ODP's and advised of the need to review alarm limits and set appropriate alarm limit values for all other cases_ Another point it is important to highlight is that the Tiro is manufactured and designed to display an "Oxygen Sensor Failure" message on the alerts screen if the FiO2 falls below 15%. This is only reasonable if it was considered impossible for machine functioning correctly to deliver such a low level of oxygen, and that therefore such reading must be due to faulty sensor_ What this case has demonstrated is that under the correct circumstances, this machine WILL deliver such an FiO2 and that for the machine to display such message under these circumstances falsely leads the anaesthetist to believe that they should disregard the Low FiO2 alarm, because the machine is telling them that the sensor is not working Although the Trust is not able to take action in respect of manufacturing issues, the Trust considers that this is something which Drager should review and we would invite the coroner to consider the same when reviewing Drager s PFD responses For example, had that message not been displayed in this case is quite possible that there would have been earlier investigation of the low FiO2 because the low FiO2 alarm would not have been disregarded, or the decision to switch to an alternative oxygen source and mechanism of ventilation might have been made earlier Implementation of AAGBL (Association of Anaesthetists of Great Britain and Ireland)_Guidance The AAGBI guidelines "Recommendations for Standards of Monitoring During Anaesthesia and Recovery December 2015'", with the relevant sections highlighted, have been circulated to all anaesthetists and Operating Department Practitioner's by the Medical Director with an outlining the outcome of the inquest, and the concerns the Coroner raised_ Notices have been placed in each anaesthetic room to remind anaesthetists of the importance of ensuring they have received training on all pieces of equipment are going to use, that have checked the anaesthetic machine_ and that have reviewed the alarm settings_ This TCA (Trained Checked Machine Alarms) methodology will become part of the routine practice of anaesthesia at the Luton & Dunstable Hospital, and will become part of the pre- operative huddle that occurs before the start of every list, including emergencies Recommendations for Standards of Monitoring during Anaesthesia and Recovery AAGBI December 2015 Available at http:/ /www aagbi org/sites/default/files/Standards_of_monitoring_2015_0-pdf Email from Dr Robin White; Medical Director to all anaesthetists and ODP'$ sent 01/09/2017 email? they they they

It is important that point out that to individually adjust all of the alarm settings on patient monitor and the anaesthetic machinelventilator takes approximately 10 minutes_ For the majority of elective operating lists, it would be feasible to set appropriate defaults for the whole list at the start of the session, and this can be done alongside the operational checks that are carried out on each machine by the anaesthetist before use_ However, the majority of machines will re-set to the default settings at the end of each case, requiring them to be re-set before each case in a list. In an emergency setting, such as was the case of Mr Woods, the anaesthetist may be actively involved in treating the patient while transporting them to the theatre. As such, there will be scenarios where it may not be possible for an Operating Department Practitioner to be able to predict what alarm settings might be appropriate for such cases Under such circumstances the case may have to commence with the default alarm settings, and fine tuning of the alarm limits may need to take place during the case_ The Trust has written to AAGBI about this separately, to ensure that there is no conflict between the guidance and emergency situations, and if necessary to seek their assistance on ensuring there is a working practice within the Trust that adheres to the guidance_ Summary The Trust believes that it has done all that it can reasonably be expected to do in addressing and raising awareness of the issues contained within the Prevention of Future Deaths Order; distributing and highlighting the current guidance available from the profession with respect to monitoring; and having in place appropriate default alarm limits which enhance patient safety. The Trust will also take forward with AAGBI the application of the guidance in emergency situations The Trust would Iike to again re-iterate our sincere apologies and best wishes to the family and friends of the late Mr Patrick Woods, and to thank the Coroner for his careful and detailed examination of the facts_ If any further information is required by the Coroner, of if he would like to discuss the letter, please do not hesitate to contact my office on or via email at Yours sincerely David Carter Acting Chief Executive Officer the put

LUTON & DUNSTABLE UNIVERSITY HOSPITAL CLINICAL EXCEL ENCE, Quaiiiy & Safety 18th August 2017 Lewsey Road Luton LU4 ODZ Tel: 01582 49 11 66 wwv Idhnhsuk PRIVATE AND CONFIDENTIAL ADDRESSEE ONLY HM Acting Senior Coroner Mr lan Pears Office of HM Coroner Bedfordshire and Luton CIO Mrs Kerry Mcllroy (Coroner's Officer) The Court House Woburn Street Ampthill Bedfordshire MK45 2HX Dear Mr Pears Regulation 28 Report to Prevent Future Deaths Court Reference 39895 2016 write in my capacity as Acting Chief Executive at Luton and Dunstable University Hospital NHS Foundation Trust ("the Trust") to address the concerns raised in the Prevention of Future Deaths Report issued following the inquest into the death of Mr Patrick Woods The matters of concern raised in the Report were:
2) The extent of the equipment portfolio held by the Hospital seemed to be unknown Without the knowledge of equipment held, no potentially dangerous equipment can be identified
3) Without the knowledge of that there is equipment that could potentially kill a patient, no risk assessment can be undertaken
4) Without a risk assessment, no action can be taken to prevent further injury to patients or fatalities The Trust has now considered the above concerns in detail and reviewed the action to be taken to prevent future deaths_ As acknowledged by the Coroner during the inquest itself, completing the actions in respect of these concerns is a time consuming task which requires substantial resources. However; on behalf of the Trust set out below those measures which are already in place, and the action which will be taken by the Trust and the timescales for the same On behalf of the Trust would Iike to reiterate our sincere apology and condolences to the family and friends of the late Mr Patrick Woods_ Action already taken It is unfortunate that it was not made clear at the time of the inquest that the Trust does hold a register of all equipment and its location within the Trust. comprehensive of equipment i.e. Manufacturer, model, serial no, device location (wardldepartment name) , commissioning date & service requirement is already held by the Trust on an electronic database managed by the Clinical Engineering department. The database also keeps record of the device history i.e. service , repair, and maintenance contract and field safety notice. In addition equipment is risk categorised into priority to 5 based on the service requirement of devices_ There is also procedure in place for commissioning/disposing of devices on the database and a formal approval process is in place anman Simon Linnett Luton and Dunstable University Hospital Ac Cme: Executivf Pauline Philip NHS Foundation Trust NHS JCL Medval Snool Cinka= Teacning Hospita: the log

for any device not already on the database and new to the trust. The department also keep a copy of agreed configuration related to specific devices and wardldepartment and ensure the device has the right dataset once it is servicedl repaired There is Training need analysis (TNA) record for each location/ward held by the Trust on database managed by the Clinical Devices Trainer. The TNA analysis contains the list of equipment specific to the wardldepartment and the devices each clinician has been trained upon and alerts the expiry of competency_ The TNA is distributed other month to Ward Managers and Matrons for accuracy and follow up_ The recording process is currently under review and the Trust is looking into an electronic database solution. The Clinical Devices Trainer along with the Clinical Educator offer regular training session to Health Care Assistants (HCA), Registered Nurses (RN), Assistant Practitioners, and Student Nurses. The Clinical Devices Trainer arranges training for doctors as and when requested In addition, at present, all incidents reported on the Trust's incident reporting system (Datix) involving faulty or any failure of equipment; are reviewed at each Medical Equipment Group meeting: The Medical Equipment Group meets two months, and all events which have been reported through Datix pertaining to medical equipment are reviewed, regardless of what local action has already been taken A decision is then made as to whether the event occurred as result of user error, equipment malfunction or improper use The results of this are then actioned by either our Clinical Devices Trainer (in the case of user error or improper use) or Clinical Engineering Manager (in the case of equipment malfunction): Because all events related to equipment are discussed at this one meeting, an overview is maintained in order to identify any themes or patterns which emerge_ The group has the power to remove an item or type of equipment if necessary, and would communicate with the Medicines and Healthcare products Regulatory Agency ("MHRA' if necessary_ The Medical Equipment Group also review and act upon all Medical Device Alerts" reported to the Trust by external agencies_ Action _to be_undertaken The Trust has considered carefully what further action needs to be undertaken, and this is set out in the below table; with the timescales for completion of the same Further action Timescale There is to be a review of each clinical area where an The "sub-lists" to be sent to each item of equipment is used_ to ensure that the Trust area by the end of September 2017 has a complete and up to date "master" log of the equipment held. The current "sub-list" of equipment for each area The Clinical Director Matron of (taken the master log) will be distributed to the each area will be required to return Clinical Director and Matron of each respective area_ the cross-checked and updated for them to review and cross-check with all equipment "sub-Iist" within two weeks of receipt in that area items in the clinical area which are of the "sub Iist" to the Chair of the not on the "sub-list' must be added. Medical Equipment Group, with a copy also sent to the Head of The Trust's Head f Clinical Risk and Governance, Clinical Risk and Governance. supported by_the_Clinical_Engineering_Manager has every every from Any

been tasked to create and distribute the 'sub-lists' to each clinical area Once the updated "sub-lists" have been received by The 'master" to be confirmed as Chair of the Medical Equipment Group and the Head updated and complete by the end of of Clinical Risk and Governance from each clinical October 2017 . area, Chair of the Medical Equipment Group must assimilate the information into the 'master" held Each "sub-list" to be stored safely by the Trust. immediately upon completion and receipt: The "sub-lists" will also be kept for each clinical area. From October 2017 the Trust will implement new Once the 'master" log and "sub- procedure whereby: lists" are completed as above, this a) new equipment entered into the Trust will new procedure will be in place_ be reviewed and entered onto both the "master log" and the appropriate "sub-list" for At every Medical Equipment Group the clinical area for where that item will be meeting (i.e: every two months) kept. The 'master and "sub-lists" will be both the "master" and "sub-lists" maintained by the Medical Equipment Group, will be reviewed to ensure and the procurement team will cross-check accuracy_ lists and provide an exception report to the Medical Equipment Group if any equipment has been bought and is not on the b) At regular intervals (every four months, i.e. at other Medical Equipment Group meeting) both the 'master" log and the "sub- lists" will be reviewed to ensure that they are accurate and up to date The Clinical Director and Matron of each area which has a "sub-list" will be asked to confirm that the same is accurate in advance of the Medical Equipment Group meeting: The Medical Equipment Group Committee will have overall responsibility for the 'master" log and "sub lists" By the end of October 2017. request will be sent to The risk assessments must take the Clinical Director and Matron of each clinical area place by the end of January 2018. which has a "sub Iist" who will then be responsible for undertaking risk assessment of the identified equipment in their area and to review the unused functionality of said equipment device_ Risk assessments will thereafter be performed Ongoing from February 2018 annually and reviewed at specific Medical Equipment Group meeting for that purpose_ The findings of the review will be reported to COBICOSQ Summary The Trust believes that it has done all that it can reasonably be expected to do in addressing the issues contained within the Prevention of Future Deaths Order; to ensure that a complete and accurate portfolio of equipment is held at all times, and that appropriate risk assessments are undertaken log log Any log the logs. every

If any further information is required by the Coroner, of ifuhewould_like to discuss the letter; please do not hesitate to contact my office on or via email at The Trust would like to again re-iterate our sincere apologies and best wishes to the family and friends of the late Mr Patrick Woods, and to thank the Coroner for his careful and detailed examination of the facts_