1 Apr 2026 Benjamin Daniel Rowley · Prevention of Future Deaths report Greater Lincolnshire
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Concerns raised 1 Failure of the permanent bond between CVC venous ports and silicone rubber tubing View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
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AI-generated summary
Benjamin Daniel Rowley · 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
On 7 November 2025, Benjamin Daniel Rowley attended dialysis when a connector on his central venous catheter disconnected, causing blood loss. He was taken to hospital, where his death was later confirmed; the stated clinical cause included haemorrhage from the catheter port. The investigation raised concerns about mechanical failure of the catheter and a possible wider vulnerability affecting this brand or dialysis lines.
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× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medtronic Limited; that does not assign responsibility.
PFD Monitor interpretation Failure of the permanent bond between CVC venous ports and silicone rubber tubing
Wider context from the report ““The CVC consists of a number of parts that are assembled during the manufacturing process. The two ports consist of a brown and a blue plastic Luer Lock connector permanently bonded to silicone rubber tubes that enter the ‘Y’ shaped connector. A white plastic sleeve is present at the point the ports enter the rubber tubing. These ports are not intended to ever be removed or detached from the silicone rubber tubes. The integrity of the permanent bond between the ports and the tubing is essential for the safety of the CVC.
[Mr Rowley] died due to exsanguination caused by a mechanical failure of the CVC. The direct cause was failure of the bond between the venous port of the CVC and the tubing, allowing the port to detach thereby causing blood returning from the machine to the patient to be expelled.”
In relation to the later incident of 11 December 2025, the relevant section of the preliminary report states:
“The nature of the failure of this CVC appears to be identical to that of Mr Rowley, namely detachment of one port of the CVC from the silicone rubber tube.
The direct cause was failure of the bond between the venous port of the CVC and the tubing, allowing the port to detach thereby causing blood returning from the machine to the patient to be expelled. The nature of the failure appears identical...”
The report concludes that:
“I am concerned that these events could represent a more widespread vulnerability of this brand or of dialysis lines and recommend reporting these events to the Medicines and Healthcare products Regulatory Agency (MHRA).”
I endorse those concerns.
” Open source report
16 Aug 2023 Devon Drew Turner · Prevention of Future Deaths report Berkshire
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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.
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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. The report was sent to Medtronic Limited; that does not assign responsibility.
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.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medtronic Limited; that does not assign responsibility.
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 .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medtronic Limited; that does not assign responsibility.
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.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medtronic Limited; that does not assign responsibility.
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.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medtronic Limited; that does not assign responsibility.
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.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medtronic Limited; that does not assign responsibility.
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.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medtronic Limited; that does not assign responsibility.
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 .
” 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 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 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
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 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
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 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
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
Concerns raised 3 Lack of post-mortem analysis of medical devices in unexplained deaths View source Inconsistent issuing of FSNs to appropriate NHS Trust recipients View source Delays in Medtronic providing safety data on request View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
×
AI-generated summary
Shayla Anne Walmsley · 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
Shayla Anne Walmsley was found deceased at her home on 9 May 2013; she had diabetes and used a Medtronic insulin pump. The cause of death remained unascertained, and the report raised concerns about delays in providing safety data, inconsistent distribution of Field Safety Notices, and failure to analyse the medical device during the post-mortem investigation.
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. The report was sent to Medtronic Limited; that does not assign responsibility.
PFD Monitor interpretation Lack of post-mortem analysis of medical devices in unexplained deaths
Wider context from the report “(3) Non-analysis of medical devices at post mortem - I am concerned that future investigations into the deaths of medical device users could be impaired by the lack of analysis of medical devices at post mortem . It is clear that these devices are increasingly being used by patients and, if death is unexplained in such a patient, appropriate analysis should be considered . As such, I believe that it is necessary to emphasise, to those involved in death investigation, the potential importance of device analysis.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medtronic Limited; that does not assign responsibility.
PFD Monitor interpretation Inconsistent issuing of FSNs to appropriate NHS Trust recipients
Wider context from the report “(2) Inconsistency in issuing FSNs - I am concerned that the apparently ad hoc nature by which FSNs are issued applies inappropriate individuals within NHS Trusts being aware of safety concerns and that this could result in future deaths. It is clear the CAS distributes MDAs to NHS Trust governance departments in a reliable manner. I believe that consideration should be made as to whether CAS could be used also to distribute FSNs.
I heard evidence from the governance department representative that this would not lead to ‘alert fatigue’ (where receipt of numerous alerts results in less attention being paid to them). This is because governance departments should be receiving these FSNs in any case and taking steps to distribute as appropriate. I heard concerns from the MHRA that this view may not be shared by all governance departments but, in my judgement, there should be consideration of the use of CAS for FSN distribution.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to Medtronic Limited; that does not assign responsibility.
PFD Monitor interpretation Delays in Medtronic providing safety data on request
Wider context from the report “(1) Interval to availability of Medtronic data - I am concerned that the investigatory role of non-US regulators could be hampered by the timescale within which Medtronic can provide data on request . Given the potential consequences of a delay in production of this safety data , I believe that future deaths could result and that this warrants consideration by Medtronic.
” Open source report
Includes reports addressed to a minister or senior office-holder acting for this organisation.
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Information checked against published PFD reports and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations