“According to the evidence heard at the inquest: 1”

The coroner’s concerns

– According to the evidence heard at the inquest: 1. Devon was discharged home on 21 April 2022 with a SATS machine from University Hospital Southampton (UHS). However, as the family lived in the Royal Berkshire NHS Foundation Trust area, and they used a different brand of SATS machine to that issued from UHS, this first machine was changed to a different second SATS machine the following day on 22 April 2022. 2. The family had been trained to use the UHS issued SATS machine. 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. 7. Action should be taken by Royal Berkshire NHS Foundation Trust to identify what happened in this instance and to ensure that such events are avoided. This may involve the local Integrated Care Board and/or MHRA. 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 MBH1920704). 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. Regulation 28 – Before Inquest Document Template Updated 30/07/2020 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 3 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. 6 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. 19. Action needs to be taken by the Trust, Integrated Care Board, MHRA, NHS England and Medtronic to investigate these events and establish whether the Medtronic SATS alarm may be insufficiently loud or may be unreliable.

An extract. Read the full report, including the circumstances of the death, on the Courts and Tribunals Judiciary website.

Source

judiciary.uk, Prevention of Future Deaths reports, 2023-0353

Added to Minute Book

8 Oct 2026

Reuse

We show short extracts and link to the original. We don’t host the full report.

Something wrong, such as a date or who it was sent to? Report a mistake

Is this report about someone close to you? You can ask us to remove names from our pages.

Contains public sector information licensed under the Open Government Licence v3.0. Source: Courts and Tribunals Judiciary, judiciary.uk. Open Government Licence v3.0