Recurring concern

Unreliable CTG equipment safety controls

First to latest report 25 Feb 2014 — 14 Oct 2021

Reports that mention this concern: 3
Times this concern has been raised: 5
Stated actions linked to this concern: 1

What this concern includes

Includes failures in CTG-equipment safety controls, including individual user accounts and access, trace visibility, display or alert functions, equipment configuration and other controls directly intended to ensure authorised staff can safely operate and interpret CTG monitoring equipment.

What is not included

Excludes CTG interpretation training, competence and clinical escalation where the equipment itself is not deficient; these belong to separate CTG interpretation concerns.
Excludes general electronic-record, staff-login or information-security failures without a direct CTG-equipment connection.
Excludes antenatal or intrapartum clinical-guidance deficiencies where CTG equipment operation is not the unsafe condition.
Excludes failures to act on a clear and reliably displayed CTG trace when the equipment operated safely.

Trends

Reports over time

Reports mentioning this concern, over time

Reports about this concern issued each year.

* 2026 is projected from reports observed to 7 Sep 2026.

Most frequent recipients

Reports about this concern sent to each recipient.

Department of Health and Social Care3

Barking, Havering and Redbridge University Hospitals NHS Trust1

Medicines and Healthcare products Regulatory Agency1

National Institute for Health and Care Excellence1

Nursing and Midwifery Council1

Portsmouth Hospitals University NHS Trust1

Queen's Hospital, Romford1

South Central Ambulance Service NHS Foundation Trust1

Reports and published responses 3 reports

See individual reports that have raised this concern, and the actions taken in response

14 Oct2021
East London
Concerns raised1
1. Failure of CTG monitoring equipment to keep the CTG trace clearly visible during delivery
This report raised 1 other concern. They are not shown here because they do not form part of this recurring concern.
No linked response statements
No respondent-stated action or position is linked to these concerns in the published data.
AI-generated summary

Louie Neil Johnston · 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

Louie Neil Johnston died in hospital on 28 April 2020 from diffuse hypoxic ischaemic encephalopathy caused by inadequate oxygen supply to his brain during delivery. The report identified avoidable delivery delays, limitations in CTG monitoring equipment, and gaps in mandatory CTG training for staff.

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 of CTG monitoring equipment to keep the CTG trace clearly visible during delivery
Wider context from the report
“1. CTG trace monitoring equipment that was in use in the labour ward required staff to switch from a CTG trace screen to a K2 electronic recording screen during delivery. This meant that a graphic representation of the CTG trace was not clearly visible at all times. Instead, midwifery staff were required to crouch down and record numeric data from the CTG displayed on a small LED screen. The Trust identified this as counter-productive and raised the issue with the manufacturer of the system. To date, the system has not been updated. ”
Source location
Louie Neil Johnston · Prevention of Future Deaths report
Page 2 · concerns
Open source report
27 Nov2017
Portsmouth and South East Hampshire
Concerns raised3
1. Failure to create CTG equipment accounts for all authorised staff
2. Poor technical quality of CTG readings during emergencies
3. Unavailability of CTG equipment in birthing centres
This report raised 9 other concerns. They are not shown here because they do not form part of this recurring concern.
Linked response

Department of Health and Social Care
Respondent positions 1
1. Department of Health and Social Care
  CTG should not be provided in low-risk birth centres because evidence shows no improved outcomes and increased unnecessary interventions.
  Disputes the concern
AI-generated summary

Rafe Robbie Angelo · 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

Rafe Robbie Angelo was born at 17:30 on 23 September 2014 after his mother was transferred from the Blake Birthing Centre to hospital during labour. He was born pale and floppy, without breathing or a heart rate, and died after 37 minutes of resuscitation. The principal concerns included delays in recognising the need for urgent delivery and communication failures between the birthing centre, ambulance service and hospital, including failure to request a time-critical transfer and a non-urgent ambulance stop.

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 create CTG equipment accounts for all authorised staff
Wider context from the report
“Ensuring an account is created for all staff authorised to use CTG equipment so that settings and prints can be run ”
Source location
Rafe Robbie Angelo · Prevention of Future Deaths report
Page 3 · concerns
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
Poor technical quality of CTG readings during emergencies
Wider context from the report
“Poor technical quality of the CTG readings at a crucial time especially given this was the first time in an emergency situation ”
Source location
Rafe Robbie Angelo · Prevention of Future Deaths report
Page 3 · concerns
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
Unavailability of CTG equipment in birthing centres
Wider context from the report
“CTG is not currently available in birthing centres and should be considered in emergency situations such as this case especially if it is not possible to transport the mother to hospital. ”
Source location
Rafe Robbie Angelo · Prevention of Future Deaths report
Page 3 · concerns
Open source report
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
CTG should not be provided in low-risk birth centres because evidence shows no improved outcomes and increased unnecessary interventions.

Verbatim wording from the response
“Birth centres are accessed by women assessed to be low risk for complications. CTG is not made available in birth centres because NICE guidance clearly states that CTG must not be offered to women at low risk of complications in established labour (Intrapartum care for healthy women and babies NICE guidance, CG190, section 1.10.1). There is no evidence that the use of CTG in low-risk women improves the fetal/neonatal outcome. I am further advised that the evidence base shows that CTGs are not recommended in a low-risk population because they have a high false positive rate, generating much unnecessary interventions such as an instrumental delivery or a caesarean section. The evidence suggests that intermittent auscultation in a low-risk population appears to be equally effective at identifying problems but does not cause as much intervention.”

Source location
2017-0421-Response-by-Department-of-Health
Page 4 · response
Published 27 February 2018
Open published response
25 Feb2014
Inner South London
Concerns raised1
1. Maternal pulse being displayed as fetal heart rate on CTG machines
This report raised 7 other concerns. They are not shown here because they do not form part of this recurring concern.
Linked response

Medicines and Healthcare products Regulatory Agency
Stated actions 1
1. Medicines and Healthcare products Regulatory Agency
  Revise CTG-use safety advice and issue current guidance as MDA 2010/054.
Respondent positions 2
1. Medicines and Healthcare products Regulatory Agency
  Insufficient user and manufacturer evidence prevents advising that older CTG units should be removed from clinical use.
  Unable to act
1. Medicines and Healthcare products Regulatory Agency
  Existing CTG safety advice and related communications are considered appropriate for those using CTG medical devices.
  Existing arrangements considered sufficient
AI-generated summary

Arthur Brockett-Deakins · 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

Arthur Brockett-Deakins was born in poor condition on 16 December 2007 after complications during labour and suffered severe disabilities resulting from acute profound perinatal hypoxic-ischaemic encephalopathy. He died at home on 18 October 2011 from respiratory problems. The report identified concerns about failure to escalate an abnormal CTG, administration and monitoring of Syntocinon, CTG interpretation and display of the maternal heart rate, and the organisation and support of a private midwifery-led service.

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
Maternal pulse being displayed as fetal heart rate on CTG machines
Wider context from the report
“3. Display of MHR as FHR on CTGs: Ms ████████ explained that if the foetus moves out of the range of the ultrasound field or the baby has sadly died, the ultrasound transducer may then pick up the maternal pulse from the aorta, iliac or uterine artery and it is displayed as the FHR and can show reactivity and variability due to MHR changes and muscle contractions can be difficult to distinguish from the FHR. It is known that the rate can be doubled or halved. The only explanation that both expert midwife and expert obstetrician could reach for the unusual CTG trace after 1pm, in the context of the state of the baby at birth, was that the maternal pulse rate was masquerading as the FHR but it had been multiplied by 1.5. The CTG machine was not the type that is known rarely to multiply by 2 and the phenomenon of a multiplication by a factor other than 2, being unknown to both experts in their distinguished careers. Evidence was not heard from the manufacturer or the product's regulatory authority. The inquest heard that new CTG machines incorporate maternal ECG or pulse oximetry, which alerts staff to investigate when MHR and FHR appear the same. But it also heard that it will take some time before all old machines are replaced. It needs to be established if multiplying by 1.5 is a possible functional feature of some machines and if so whether either it can be designed away or whether dissemination or guidance or an action by the regulatory authority is needed to prevent it leading to a fatality or child disability. ”
Source location
Arthur Brockett-Deakins · Prevention of Future Deaths report
Page 2 · concerns
Open source report
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
Revise CTG-use safety advice and issue current guidance as MDA 2010/054.

Verbatim wording from the response
“Our advice on CTG use was revised in 2010 to become MDA 2010/054, and is our current advice.”

Source location
2014-0077-Response-by-Medicines-Healthcare-Products-Regulatory-Agency
Page 2 · response
Published 25 February 2014
Open published response
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
Insufficient user and manufacturer evidence prevents advising that older CTG units should be removed from clinical use.

Verbatim wording from the response
“Modern CTG units now incorporate maternal ECG or pulse oximetry functions and many have prompts to double-check if readings of MHR x 2 occur. It is possible that some older units remain in clinical use but there is insufficient evidence provided by users and manufacturers for MHRA to advise that they should be removed from use.”

Source location
2014-0077-Response-by-Medicines-Healthcare-Products-Regulatory-Agency
Page 2 · response
Published 25 February 2014
Open published response
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 CTG safety advice and related communications are considered appropriate for those using CTG medical devices.

Verbatim wording from the response
“Our advice on CTG use was revised in 2010 to become MDA 2010/054, and is our current advice.”

Source location
2014-0077-Response-by-Medicines-Healthcare-Products-Regulatory-Agency
Page 2 · response
Published 25 February 2014
Open published response