30 Apr 2026 Poppy Hope LOMAS · Prevention of Future Deaths report North London
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Concerns raised 1
Unavailability of a pulse oximeter for maternal heart rate in the home delivery kit View source
This report raised 3 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Poppy Hope LOMAS · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Poppy Hope LOMAS died in hospital on 26 October 2022, aged 7 days, after being born in poor condition following a home delivery. The report describes multiple unrecognised risk factors during the delivery and identifies concerns about consent and risk communication, multidisciplinary review, terminology used for unsafe deliveries, and the absence of a maternal pulse oximeter from the home delivery kit.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Unavailability of a pulse oximeter for maternal heart rate in the home delivery kit
Wider context from the report “It is a matter of concern that the Home Delivery kit does not include a pulse oximeter for maternal heart rate .
” Source location Poppy Hope LOMAS · Prevention of Future Deaths report
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Set minimum standards for safe homebirth services, including clear terminology, safety and risk assessment, multidisciplinary care planning, consent documentation, and standardised equipment.
Verbatim wording from the response “By autumn 2026, we anticipate setting out the minimum standards that providers and commissioners of maternity services will be expected to meet to support the delivery of a safe, effective, equitable and personalised home birth service. The standards will include the use of appropriate and clear language in discussing women’s preferences, including review of the term “Out of Guidance”. The standards will also include detail on the assessment of safety and risk required, and the need for multi-disciplinary team working in the formulation of care plans and their documentation. This will also include consideration of the use of consent forms which are not currently used in maternity services for any place of birth. It will also include reference to the standardised equipment required for clinical care provided during homebirth.” Source location Response from NHS England
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The contents of home delivery kits are outside NICE’s remit and are better addressed by other organisations.
Verbatim wording from the response “The specific contents of home delivery kits issued to midwives for use during home births is not a matter for NICE. Other organisations such as the RCM and specialist societies are better placed to make recommendations in this area.” Source location Response from National Institute for Health and Care Excellence
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Responsibility for the specific homebirth concerns sits with NHS England, which will issue the substantive response.
Verbatim wording from the response “In preparing this response, my officials have made enquiries with NHS England to ensure we adequately address your concerns, and I understand there is work underway to develop national standards and a clear framework for homebirth services. As responsibility for the specific matters of concern you have raised sits with NHS England, they will be issuing a substantive response addressing each of these concerns.” Source location Response from Department of Health and Social Care
Open published response
16 Aug 2023 Devon Drew Turner · Prevention of Future Deaths report Berkshire
View report summary
Concerns raised 7
Failure to ensure that SATS machines are suitable and easy to use at home View source Failure to train parents to use the particular SATS machine brand issued View source Failure of SATS machine alarm volume to wake sleeping parents View source
Failure to ensure the reliability of SATS machines sent home with vulnerable patients View source Failure of SATS machine alarms to sound reliably View source Failure to provide accurate SATS machine event data and analysis View source Failure of SATS machine alarms to remain active or sound when required View source See 4 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
Respondent positions A position is what a respondent says about the concern when they do not describe a specific action. 9
Position
No further action is needed to identify what happened regarding the SATS machines’ reliability and ease of use after review of the evidence.
Stated by Buckinghamshire, Oxfordshire and Berkshire West Integrated Care BoardNo action considered necessaryThe respondent said that no further action was needed. View source
Position
The device specification, alarm settings, home suitability and functioning fall outside NHS England’s remit and within MHRA’s regulatory remit.
Stated by NHS EnglandOutside remitThe respondent said that this matter was outside its role or authority. View source
Position
The device was functioning reliably, accurately recording data, and suitable for home use; retained data and testing did not support the reported concerns.
Stated by Medtronic LimitedDisputes the concernThe respondent disagreed with part of the concern or the basis for it. View source
Position
The healthcare provider is responsible for configuring device settings to meet each patient’s clinical needs and intended location of use.
Stated by Medtronic LimitedRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action. View source
Position
Existing manuals, home-use guidance, and healthcare-professional training were considered sufficient to support safe hospital and home use.
Stated by Medtronic LimitedExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed. View source
Position
Because the device was considered appropriately functioning, accurate, and suitable for home use, no modification or change was considered necessary.
Stated by Medtronic LimitedNo action considered necessaryThe respondent said that no further action was needed. View source
Position
No further action is needed to investigate events concerning the Medtronic SATS machine alarm’s loudness and reliability because the investigation has been undertaken.
Stated by Buckinghamshire, Oxfordshire and Berkshire West Integrated Care BoardNo action considered necessaryThe respondent said that no further action was needed. View source
Position
There are no known patient-safety issues relating generally to SATS machine alarms, and no similar incidents are known.
Stated by NHS EnglandDisputes the concernThe respondent disagreed with part of the concern or the basis for it. View source
Position
MHRA is responsible for investigating the monitor concerns and ensuring that any identified actions are undertaken.
Stated by NHS EnglandRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action. View source See 8 more positions
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AI-generated summary
Devon Drew Turner · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Devon Drew Turner, who had Mosaic Trisomy 9 and significant respiratory vulnerability, died at hospital on 10 May 2022 after being found unresponsive at home. The report raises concerns about the reliability, suitability, alarm function and data recording of SATS monitoring machines provided for use by vulnerable babies at home, including whether parents were adequately trained on the particular device supplied.
Read the report on judiciary.uk
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to ensure that SATS machines are suitable and easy to use at home
Wider context from the report “Matter of Concern 1:
3. On 25 April 2022 this second SATS machine, stopped working. It had some sort of error message on the screen. The parents contacted the community nurse team and Devon’s mother had to attend the hospital that night to pick up a new SATS machine.
4. Therefore the first concern is regarding the reliability of such SATS machines sent home with vulnerable patients.
5. If a safety plan is put in place which includes the use of a SATS machine to monitor the wellbeing of the patient, and that machine is less than at least 99% reliable, or has software issues, or is unsuitable for home use, or is complicated to use , this may result in a false sense of security from the family who will rely on the machine to alert them if the oxygen levels drop below a certain figure.
6. Therefore there is a risk that future deaths will occur if hospital trusts do not ensure that the SATS machines are reliable and easy to use and that parents are trained to use the particular brand they are issued with.
” Source location Devon Drew Turner · Prevention of Future Deaths report
Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to train parents to use the particular SATS machine brand issued
Wider context from the report “Matter of Concern 1:
3. On 25 April 2022 this second SATS machine, stopped working. It had some sort of error message on the screen. The parents contacted the community nurse team and Devon’s mother had to attend the hospital that night to pick up a new SATS machine.
4. Therefore the first concern is regarding the reliability of such SATS machines sent home with vulnerable patients.
5. If a safety plan is put in place which includes the use of a SATS machine to monitor the wellbeing of the patient, and that machine is less than at least 99% reliable, or has software issues, or is unsuitable for home use, or is complicated to use, this may result in a false sense of security from the family who will rely on the machine to alert them if the oxygen levels drop below a certain figure.
6. Therefore there is a risk that future deaths will occur if hospital trusts do not ensure that the SATS machines are reliable and easy to use and that parents are trained to use the particular brand they are issued with .
” Source location Devon Drew Turner · Prevention of Future Deaths report
Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure of SATS machine alarm volume to wake sleeping parents
Wider context from the report “Matter of Concern 2:
8. The third machine was issued to the family on 25 April 2022, which remained with them until Devon’s death. It was manufactured by Medtronic (Model number MBB1920904). It is not known if this was the same brand as the second SATS machine mentioned above.
9. The concern is that this Medtronic machine was also either not functioning reliably or was not suitable for the home environment.
10. On 10 May 2022 Devon was given his 1am feed and the family settled down to sleep. At 4.30am Devon’s mother woke to find him unresponsive. The CPAP machine log confirms those two times.
11. The SATS machine was seized by the police on 10 May 2022.
12. Medtronic technician, ████████ made a statement dated 6/7/2022 which I append to this Report, in which he states that:
• The testing of the SATS machine revealed that it was functioning properly
• The data from the machine shows that from approximately 1.44am Devon’s oxygen saturations started to drop and continued to fall until approximately 2.00am when there was no pulse.
• The alarm would have been sounding throughout that time and that at the loss of pulse, at 2.00am a further alarm would have sounded.
• The machine alarm was at maximum volume
• There is a silence button on the machine but that it only silences the alarm for 60 seconds, after which interval the alarm would sound again throughout the whole period that the saturation levels were low.
13. Given the crucial role a SATS machine has in monitoring a vulnerable baby at home, with non-medically trained carers who need to sleep, there should be no doubt but that the alarm sound will sound reliably, that its volume will wake sleeping exhausted parents and should provide an accurate log of events.
14. The conclusions that the data from the SATS machine appear to provide do not accord with the other evidence provided to the inquest about the events in question. That gives cause for concern that either the analysis of the SATS machine has not been accurate or the SATS machine has not correctly recorded the data or that this SATS machine is not a suitable device for use at home.
15. For example, the community nurses would have noticed if the SATS machine was not working in the first weeks of Devon being at home and yet it has recorded that it was not used at all until 31 May 2022.
16. Secondly in order for the SATS machine data to have been correct about events of 10 May 2022, either both the parents would have had to sleep through an alarm sounding for at least 15 minutes at full volume as well as a second alarm after 15 minutes at the loss of pulse, or the parents would have had to have used the silence button on the alarm system every 60 seconds for that 15 minute period.
17. The SATS machine silence button was not within reach of Devon’s mother unless she sat up and reached up and over baby Devon in his cot. Devon’s father would have had to get out of bed altogether. A copy of the police photographs of the bedroom on 10 May 2022 is attached to this report. It is inconceivable that these concerned and careful parents, who had taken such an active role in Devon’s care, would have turned off this alarm in this way several times and failed to notice his respiratory distress, and when he was found unresponsive, would have forgotten that they had silenced the alarm in this way. Therefore either the SATS machine did not function as it should or was not sufficiently loud to wake either of these careful parents.
18. The potential for future deaths is that future parents will also rely on the SATS machine to alert them to a vulnerable child stopping breathing and taking action will not be alerted because either the alarm is too quiet , or it cuts out automatically before waking the parents, or it simply does not sound at all.
” Source location Devon Drew Turner · Prevention of Future Deaths report
Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to ensure the reliability of SATS machines sent home with vulnerable patients
Wider context from the report “Matter of Concern 1:
3. On 25 April 2022 this second SATS machine, stopped working. It had some sort of error message on the screen. The parents contacted the community nurse team and Devon’s mother had to attend the hospital that night to pick up a new SATS machine.
4. Therefore the first concern is regarding the reliability of such SATS machines sent home with vulnerable patients .
5. If a safety plan is put in place which includes the use of a SATS machine to monitor the wellbeing of the patient, and that machine is less than at least 99% reliable , or has software issues, or is unsuitable for home use, or is complicated to use, this may result in a false sense of security from the family who will rely on the machine to alert them if the oxygen levels drop below a certain figure.
6. Therefore there is a risk that future deaths will occur if hospital trusts do not ensure that the SATS machines are reliable and easy to use and that parents are trained to use the particular brand they are issued with.
” Source location Devon Drew Turner · Prevention of Future Deaths report
Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure of SATS machine alarms to sound reliably
Wider context from the report “Matter of Concern 2:
8. The third machine was issued to the family on 25 April 2022, which remained with them until Devon’s death. It was manufactured by Medtronic (Model number MBB1920904). It is not known if this was the same brand as the second SATS machine mentioned above.
9. The concern is that this Medtronic machine was also either not functioning reliably or was not suitable for the home environment.
10. On 10 May 2022 Devon was given his 1am feed and the family settled down to sleep. At 4.30am Devon’s mother woke to find him unresponsive. The CPAP machine log confirms those two times.
11. The SATS machine was seized by the police on 10 May 2022.
12. Medtronic technician, ████████ made a statement dated 6/7/2022 which I append to this Report, in which he states that:
• The testing of the SATS machine revealed that it was functioning properly
• The data from the machine shows that from approximately 1.44am Devon’s oxygen saturations started to drop and continued to fall until approximately 2.00am when there was no pulse.
• The alarm would have been sounding throughout that time and that at the loss of pulse, at 2.00am a further alarm would have sounded.
• The machine alarm was at maximum volume
• There is a silence button on the machine but that it only silences the alarm for 60 seconds, after which interval the alarm would sound again throughout the whole period that the saturation levels were low.
13. Given the crucial role a SATS machine has in monitoring a vulnerable baby at home, with non-medically trained carers who need to sleep, there should be no doubt but that the alarm sound will sound reliably , that its volume will wake sleeping exhausted parents and should provide an accurate log of events.
14. The conclusions that the data from the SATS machine appear to provide do not accord with the other evidence provided to the inquest about the events in question. That gives cause for concern that either the analysis of the SATS machine has not been accurate or the SATS machine has not correctly recorded the data or that this SATS machine is not a suitable device for use at home.
15. For example, the community nurses would have noticed if the SATS machine was not working in the first weeks of Devon being at home and yet it has recorded that it was not used at all until 31 May 2022.
16. Secondly in order for the SATS machine data to have been correct about events of 10 May 2022, either both the parents would have had to sleep through an alarm sounding for at least 15 minutes at full volume as well as a second alarm after 15 minutes at the loss of pulse, or the parents would have had to have used the silence button on the alarm system every 60 seconds for that 15 minute period.
17. The SATS machine silence button was not within reach of Devon’s mother unless she sat up and reached up and over baby Devon in his cot. Devon’s father would have had to get out of bed altogether. A copy of the police photographs of the bedroom on 10 May 2022 is attached to this report. It is inconceivable that these concerned and careful parents, who had taken such an active role in Devon’s care, would have turned off this alarm in this way several times and failed to notice his respiratory distress, and when he was found unresponsive, would have forgotten that they had silenced the alarm in this way. Therefore either the SATS machine did not function as it should or was not sufficiently loud to wake either of these careful parents.
18. The potential for future deaths is that future parents will also rely on the SATS machine to alert them to a vulnerable child stopping breathing and taking action will not be alerted because either the alarm is too quiet, or it cuts out automatically before waking the parents, or it simply does not sound at all.
” Source location Devon Drew Turner · Prevention of Future Deaths report
Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to provide accurate SATS machine event data and analysis
Wider context from the report “Matter of Concern 2:
8. The third machine was issued to the family on 25 April 2022, which remained with them until Devon’s death. It was manufactured by Medtronic (Model number MBB1920904). It is not known if this was the same brand as the second SATS machine mentioned above.
9. The concern is that this Medtronic machine was also either not functioning reliably or was not suitable for the home environment.
10. On 10 May 2022 Devon was given his 1am feed and the family settled down to sleep. At 4.30am Devon’s mother woke to find him unresponsive. The CPAP machine log confirms those two times.
11. The SATS machine was seized by the police on 10 May 2022.
12. Medtronic technician, ████████ made a statement dated 6/7/2022 which I append to this Report, in which he states that:
• The testing of the SATS machine revealed that it was functioning properly
• The data from the machine shows that from approximately 1.44am Devon’s oxygen saturations started to drop and continued to fall until approximately 2.00am when there was no pulse.
• The alarm would have been sounding throughout that time and that at the loss of pulse, at 2.00am a further alarm would have sounded.
• The machine alarm was at maximum volume
• There is a silence button on the machine but that it only silences the alarm for 60 seconds, after which interval the alarm would sound again throughout the whole period that the saturation levels were low.
13. Given the crucial role a SATS machine has in monitoring a vulnerable baby at home, with non-medically trained carers who need to sleep, there should be no doubt but that the alarm sound will sound reliably, that its volume will wake sleeping exhausted parents and should provide an accurate log of events .
14. The conclusions that the data from the SATS machine appear to provide do not accord with the other evidence provided to the inquest about the events in question. That gives cause for concern that either the analysis of the SATS machine has not been accurate or the SATS machine has not correctly recorded the data or that this SATS machine is not a suitable device for use at home.
15. For example, the community nurses would have noticed if the SATS machine was not working in the first weeks of Devon being at home and yet it has recorded that it was not used at all until 31 May 2022.
16. Secondly in order for the SATS machine data to have been correct about events of 10 May 2022, either both the parents would have had to sleep through an alarm sounding for at least 15 minutes at full volume as well as a second alarm after 15 minutes at the loss of pulse, or the parents would have had to have used the silence button on the alarm system every 60 seconds for that 15 minute period.
17. The SATS machine silence button was not within reach of Devon’s mother unless she sat up and reached up and over baby Devon in his cot. Devon’s father would have had to get out of bed altogether. A copy of the police photographs of the bedroom on 10 May 2022 is attached to this report. It is inconceivable that these concerned and careful parents, who had taken such an active role in Devon’s care, would have turned off this alarm in this way several times and failed to notice his respiratory distress, and when he was found unresponsive, would have forgotten that they had silenced the alarm in this way. Therefore either the SATS machine did not function as it should or was not sufficiently loud to wake either of these careful parents.
18. The potential for future deaths is that future parents will also rely on the SATS machine to alert them to a vulnerable child stopping breathing and taking action will not be alerted because either the alarm is too quiet, or it cuts out automatically before waking the parents, or it simply does not sound at all.
” Source location Devon Drew Turner · Prevention of Future Deaths report
Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure of SATS machine alarms to remain active or sound when required
Wider context from the report “Matter of Concern 2:
8. The third machine was issued to the family on 25 April 2022, which remained with them until Devon’s death. It was manufactured by Medtronic (Model number MBB1920904). It is not known if this was the same brand as the second SATS machine mentioned above.
9. The concern is that this Medtronic machine was also either not functioning reliably or was not suitable for the home environment.
10. On 10 May 2022 Devon was given his 1am feed and the family settled down to sleep. At 4.30am Devon’s mother woke to find him unresponsive. The CPAP machine log confirms those two times.
11. The SATS machine was seized by the police on 10 May 2022.
12. Medtronic technician, ████████ made a statement dated 6/7/2022 which I append to this Report, in which he states that:
• The testing of the SATS machine revealed that it was functioning properly
• The data from the machine shows that from approximately 1.44am Devon’s oxygen saturations started to drop and continued to fall until approximately 2.00am when there was no pulse.
• The alarm would have been sounding throughout that time and that at the loss of pulse, at 2.00am a further alarm would have sounded.
• The machine alarm was at maximum volume
• There is a silence button on the machine but that it only silences the alarm for 60 seconds, after which interval the alarm would sound again throughout the whole period that the saturation levels were low.
13. Given the crucial role a SATS machine has in monitoring a vulnerable baby at home, with non-medically trained carers who need to sleep, there should be no doubt but that the alarm sound will sound reliably, that its volume will wake sleeping exhausted parents and should provide an accurate log of events.
14. The conclusions that the data from the SATS machine appear to provide do not accord with the other evidence provided to the inquest about the events in question. That gives cause for concern that either the analysis of the SATS machine has not been accurate or the SATS machine has not correctly recorded the data or that this SATS machine is not a suitable device for use at home.
15. For example, the community nurses would have noticed if the SATS machine was not working in the first weeks of Devon being at home and yet it has recorded that it was not used at all until 31 May 2022.
16. Secondly in order for the SATS machine data to have been correct about events of 10 May 2022, either both the parents would have had to sleep through an alarm sounding for at least 15 minutes at full volume as well as a second alarm after 15 minutes at the loss of pulse, or the parents would have had to have used the silence button on the alarm system every 60 seconds for that 15 minute period.
17. The SATS machine silence button was not within reach of Devon’s mother unless she sat up and reached up and over baby Devon in his cot. Devon’s father would have had to get out of bed altogether. A copy of the police photographs of the bedroom on 10 May 2022 is attached to this report. It is inconceivable that these concerned and careful parents, who had taken such an active role in Devon’s care, would have turned off this alarm in this way several times and failed to notice his respiratory distress, and when he was found unresponsive, would have forgotten that they had silenced the alarm in this way. Therefore either the SATS machine did not function as it should or was not sufficiently loud to wake either of these careful parents.
18. The potential for future deaths is that future parents will also rely on the SATS machine to alert them to a vulnerable child stopping breathing and taking action will not be alerted because either the alarm is too quiet, or it cuts out automatically before waking the parents, or it simply does not sound at all .
” Source location Devon Drew Turner · Prevention of Future Deaths report
Open source report
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Provide families using saturation monitors with user training, equipment-loan documentation and instructions to report faults or damage.
Verbatim wording from the response “1) Did the family receive training, in line with recognised Trust processes, to use the saturation monitor that was given to them on 22 April?
The Community Children’s Nurse [CCN] recorded in Devon’s clinical record that she had explained to the parent how to use the handheld and bedside oxygen saturation monitors on the day she gave them the equipment. This was in line with Trust processes. At the first home visit by the CCN all the equipment in use was reviewed, checked, and documented in Devon’s clinical record. Berkshire Healthcare's ‘Acknowledgement and terms of Equipment loan’ document was completed and signed by the parent and the CCN at the next home visit on 27 April 2022.” Source location Response from Buckinghamshire, Oxfordshire and Berkshire West Integrated Care Board
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Maintain saturation monitors through visual and functional checks before allocation, annual planned preventative maintenance, service-date controls and an equipment inventory.
Verbatim wording from the response “5) Was the saturation monitor supplied to the family by Berkshire Healthcare on 22 April checked and maintained in line with the Trust's maintenance specifications?
All equipment supplied to Devon had been checked by the CCN before allocation, was within its service dates and had been serviced annually as per manufacturers guidelines.” Source location Response from Buckinghamshire, Oxfordshire and Berkshire West Integrated Care Board
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Investigate reported monitor faults, send equipment for review or repair, issue replacements and maintain records of repairs and planned maintenance.
Verbatim wording from the response “6) Have there been any other reports from families/users or staff of faults with the type of saturation monitor supplied to the family on 22 April? If so, what actions have been taken to investigate/rectify these?
Nellcor is the only make of oxygen saturation monitor that the CCN service provide to families. The parents’ report of a fault on 25 April regarding the machine supplied to them on 22 April is the only instance recorded of a fault of this kind with this type of equipment. All reported faults are listened to and acted upon by the team and equipment is sent for review and repair, and replacement equipment is issued. The team hold a pool of equipment to replace any items that need to be sent for repair or for annual maintenance. A clear record is kept of when oxygen saturation monitors have been brought in for” Source location Response from Buckinghamshire, Oxfordshire and Berkshire West Integrated Care Board
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Maintain a pool of replacement monitors and provide families with additional equipment so faults or scheduled maintenance do not leave them without monitoring capacity.
Verbatim wording from the response “6) Have there been any other reports from families/users or staff of faults with the type of saturation monitor supplied to the family on 22 April? If so, what actions have been taken to investigate/rectify these?
Nellcor is the only make of oxygen saturation monitor that the CCN service provide to families. The parents’ report of a fault on 25 April regarding the machine supplied to them on 22 April is the only instance recorded of a fault of this kind with this type of equipment. All reported faults are listened to and acted upon by the team and equipment is sent for review and repair, and replacement equipment is issued. The team hold a pool of equipment to replace any items that need to be sent for repair or for annual maintenance. A clear record is kept of when oxygen saturation monitors have been brought in for” Source location Response from Buckinghamshire, Oxfordshire and Berkshire West Integrated Care Board
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Maintain formal verification and validation of software used to download device data accurately.
Verbatim wording from the response “During the physical examination and functional testing of the PM100N device and subsequent data download, the Medtronic Service Technician, whose first language is Italian, explained to DC 7712 the test of his ability, the nature of the checks he was completing and the findings from the data download. He also emailed to DC 7712 a copy of the downloaded data from the device memory and an Excel spreadsheet of the same data that day.” Source location Response from Medtronic
Open published response
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation No further action is needed to identify what happened regarding the SATS machines’ reliability and ease of use after review of the evidence.
Verbatim wording from the response “Your Regulation 28 Report asked the ICB to take action to identify what happened in relation to the reliability and ease of use of the SATS machines being used. The ICB and the MHRA have been involved in the oversight of the review of the machine and, following a review of the evidence presented at the inquest, the ICB feel that there is no further action needed in order to Prevent Future Deaths.” Source location Response from Buckinghamshire, Oxfordshire and Berkshire West Integrated Care Board
Open published response
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The device specification, alarm settings, home suitability and functioning fall outside NHS England’s remit and within MHRA’s regulatory remit.
Verbatim wording from the response “From your Report the underlying issue relates to the specification of the SATS machine used, its alarm settings and volume, whether it was suitable for use in a patient’s home and whether the machine in this case was working properly. These issues would fall under the remit of the Medicines and Healthcare products Regulatory Agency (MHRA), who are the regulator for all medical devices in the UK, who I note that you have also addressed your concerns to.” Source location Response from NHS England
Open published response
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The device was functioning reliably, accurately recording data, and suitable for home use; retained data and testing did not support the reported concerns.
Verbatim wording from the response “Alarms were tested and found to be functioning according to the device specification. The device patient mode was in paediatric mode and the ‘nurse call’ appeared to function normally (albeit this is a function which can only be used with a nurse call infrastructure, usually in a healthcare setting and not in the home). The PM100N device was tested with a SpO2 simulator and passed the tests as per manufacturer service instructions. The PM100N device was also tested with a spotlight SpO2 functional tester at its maximum values BPM 240 and SpO2 100% and passed all tests. The PM100N device monitor was fully checked for functionality and electrical safety and passed all tests successfully as per the manufacturer guideline.” Source location Response from Medtronic
Open published response
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The healthcare provider is responsible for configuring device settings to meet each patient’s clinical needs and intended location of use.
Verbatim wording from the response “The PM100N device is intended for use both in a hospital and (with a slightly adapted range of functionality) a home setting in the UK. This enables patients (and their carers) to have the comfort of living in their own homes whilst receiving care. From the photographs provided to HM Assistant Coroner by the police, the PM100N device was not set to operate in “homecare mode” at the time of death. This is because the photographs of the PM100N device display screen do not show a “house” symbol, which would have been displayed had home use setting been applied. Activating the “homecare mode” setting is for the healthcare provider to decide along with the appropriate settings for the individual patient in order to meet their medical needs (see below).” Source location Response from Medtronic
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Existing manuals, home-use guidance, and healthcare-professional training were considered sufficient to support safe hospital and home use.
Verbatim wording from the response “PM100N devices are supplied by Medtronic to healthcare providers (i.e. hospitals) in the UK. They are supplied with an Operator’s Manual and also a Home Use Guide.” Source location Response from Medtronic
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Because the device was considered appropriately functioning, accurate, and suitable for home use, no modification or change was considered necessary.
Verbatim wording from the response “Based on the investigations carried out by Medtronic both before and following receipt of the Regulation 28: Report to Prevent Future Deaths dated 18 August 2023 and the subsequent documents received on 9 October 2023, it appears to Medtronic that the PM100N device used by the Deceased was functioning appropriately at all material times, that it was accurately recording data and was accordingly suitable for home use. In light of these conclusions, Medtronic does not consider that modification or change is required to the device in question.” Source location Response from Medtronic
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation No further action is needed to investigate events concerning the Medtronic SATS machine alarm’s loudness and reliability because the investigation has been undertaken.
Verbatim wording from the response “You also ask that the trusts, ICB, MHRA, NHSE and Medtronic investigate the events leading up to the death in relation to the loudness and reliability of the alarm on the Medtronic SATS machine. This has been undertaken as described above and the ICB, on behalf of all partners, feel that there is no further action to be taken in order to Prevent Future Deaths.” Source location Response from Buckinghamshire, Oxfordshire and Berkshire West Integrated Care Board
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation There are no known patient-safety issues relating generally to SATS machine alarms, and no similar incidents are known.
Verbatim wording from the response “On receipt of your Report, it was shared with colleagues from NHS England’s central Patient Safety (including medical device specialists) and Children & Young People teams as well as my regional Quality colleagues in the South East. The Patient Safety Team reviewed the concerns raised and have confirmed that they are not aware of similar incidents and that there are no known patient safety issues relating to SATS machine alarms in general.” Source location Response from NHS England
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation MHRA is responsible for investigating the monitor concerns and ensuring that any identified actions are undertaken.
Verbatim wording from the response “From your Report the underlying issue relates to the specification of the SATS machine used, its alarm settings and volume, whether it was suitable for use in a patient’s home and whether the machine in this case was working properly. These issues would fall under the remit of the Medicines and Healthcare products Regulatory Agency (MHRA), who are the regulator for all medical devices in the UK, who I note that you have also addressed your concerns to.” Source location Response from NHS England
Open published response
Concerns raised 1
Failure to set pulse oximeter alarm levels to reflect individual patients’ baseline oxygen saturations View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
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AI-generated summary
Kay Michelle Sheard · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Kay Michelle Sheard underwent an outpatient procedure under sedation for removal of gall stones from the bile duct and subsequently suffered cardiorespiratory failure. The report raised concern that pulse oximeter alarm settings were routinely fixed at 85% without taking account of the individual patient’s normal oxygen saturation or the extent of a drop from that baseline.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to set pulse oximeter alarm levels to reflect individual patients’ baseline oxygen saturations
Wider context from the report “During the procedure the Deceased’s oxygen saturations were being monitored by a pulse oximeter for which I was advised that the alarm settings are routinely set at 85% . However all evidence indicated that it was the actual level of reading which would be significant for a patient but rather the amount by which saturations had dropped from the patient’s normal base level . Notwithstanding this, the evidence indicated that this would not be taken into account when fixing an alarm setting level and I am therefore concerned that there exists a potential risk to patients which could be reduced or eliminated by ensuring that the alarm level correctly reflects the individual patient’s condition.
” Source location Kay Michelle Sheard · Prevention of Future Deaths report
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Check pulse oximeter alarm settings across approximately 1,200 devices.
Verbatim wording from the response “Since receiving the report BCU has done a significant amount of work in reviewing device holdings, checking device settings, and scoping the Action Plan for an inventory of approximately 1200 devices of varying complexity across the Health Board.” Source location Kay-Sheard-Response
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Scope an action plan addressing pulse oximeter alarm-level safety.
Verbatim wording from the response “Since receiving the report BCU has done a significant amount of work in reviewing device holdings, checking device settings, and scoping the Action Plan for an inventory of approximately 1200 devices of varying complexity across the Health Board.” Source location Kay-Sheard-Response
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How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Raise pulse oximeter alarm-setting issues at Welsh and UK level through the MHRA.
Verbatim wording from the response “A number of national and international bodies have produced guidelines on pulse oximetry. The Health Board has a significant amount of work to do on this issue, noting that pulse oximetry is used so widely, by so many different staff, in different clinical situations. However, our inquiries indicate that this issue also extends beyond the Health Board to the manufacturers, who install default alarm levels in their products, and the extent to which they support and facilitate user adjustment of alarm levels. Accordingly there are likely to be issues to be considered beyond BCU Health Board, and we will raise these both at Wales level, and at UK level through the MHRA (Medicines and Healthcare products Regulatory Agency).” Source location Kay-Sheard-Response
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How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Some pulse oximetry alarm-setting issues concern manufacturers and should be addressed through Wales- and UK-level channels, including the MHRA.
Verbatim wording from the response “A number of national and international bodies have produced guidelines on pulse oximetry. The Health Board has a significant amount of work to do on this issue, noting that pulse oximetry is used so widely, by so many different staff, in different clinical situations. However, our inquiries indicate that this issue also extends beyond the Health Board to the manufacturers, who install default alarm levels in their products, and the extent to which they support and facilitate user adjustment of alarm levels. Accordingly there are likely to be issues to be considered beyond BCU Health Board, and we will raise these both at Wales level, and at UK level through the MHRA (Medicines and Healthcare products Regulatory Agency).” Source location Kay-Sheard-Response
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9 May 2014 Lisa Webb · Prevention of Future Deaths report Inner South London
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Concerns raised 1
Failure to use pulse oximetry in respiratory assessment View source
This report raised 4 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No respondent-stated action or position is linked to these concerns in the published data.
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AI-generated summary
Lisa Webb · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Lisa Webb died suddenly and unexpectedly at home on 10 March 2012, aged 44. The inquest recorded natural causes, including adult respiratory distress syndrome and lower respiratory tract infection, with sleep apnoea and chronic asthma noted. Expert evidence raised concerns about the general practitioner's assessment and management of her asthma and respiratory symptoms, including the prescription of Diazepam.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Failure to use pulse oximetry in respiratory assessment
Wider context from the report “Expert evidence was heard that:
(1) The management of asthma by the general practitioner on 9th March 2012, when she presented post-operatively with fast breathing and anxiety, was sub-optimal and creates potential risks for other patients.
a) Enquiries about her asthma and use of inhalers were not made, before a diagnosis was made of anxiety related hyperventilation (which was not in previous medical history)
b) Fast breathing was observed and recorded (sic hyperventilating and mild wheeze, but the respiratory rate not recorded, nor was her pulse rate.
c) Her peak flow rate was not recorded. There was only one record of its being measured in the years of general practice care and that was in 2008, when she was given a steroid inhaler.
d) Pulse oximetry was not used
(2) The prescription of Diazepam, although it did no harm in this instance, was poor treatment for anxiety, it should not be prescribed in sleep apnoea; and ideally should be avoided in respiratory distress. The GP said that he would not have given it in an asthmatic unless she had it before (of which there was no record) and that he was unaware of the diagnosis of sleep apnoea (of which diagnosis there was also no medical record).
” Source location Lisa Webb · Prevention of Future Deaths report
Open source report
28 Nov 2013 Doris Phoebe Miller · Prevention of Future Deaths report Milton Keynes
View report summary
Concerns raised 1
Unavailability of a pulse oximeter in the GP surgery View source
This report raised 2 other concerns. They are not shown here because they do not form part of this recurring concern.
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No respondent-stated action or position is linked to these concerns in the published data.
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AI-generated summary
Doris Phoebe Miller · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
The circumstances of Doris Phoebe Miller’s death are not provided in the supplied text. Concerns included the GP surgery’s lack of access to her transferred medical records, ineffective communication about an urgent blood test, and the absence of a pulse oximeter at the surgery.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below.
PFD Monitor interpretation Unavailability of a pulse oximeter in the GP surgery
Wider context from the report “(3) During the inquest hearing it became apparent that the surgery at Broughton Gate did not have access to a pulse oximeter to measure Mrs Miller’s oxygenation . This is a relatively inexpensive item and should perhaps be available in every doctor’s surgery throughout the country.
” Source location Doris Phoebe Miller · Prevention of Future Deaths report
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Includes failures of pulse-oximeter availability, suitability, reliability, serviceability, user training or clinically indicated use in home, primary, community or hospital care.
