- Medicines and Healthcare products Regulatory Agency
- 2 August 2016
- 2 August 2016
- Alert type:
- Medical device alert
In skin-temperature control mode, if the temperature sensor is not connected or detaches from the patient, the heating element may overheat causing particles to detach; potentially leading to fire and patient harm or death.
- Identify users of the Babytherm® 8004/8010 Infant Warmer.
- Ensure that all users receive the manufacturer’s Field Safety Notice (FSN) and that they understand the problem and the advice given by the manufacturer.
- Users are advised to use manual mode instead of skin-temperature control mode.
- If skin-temperature control mode is used, ensure temperature sensor is secured to the patient before use, as per advice given in manufacturer’s FSN.
- Ensure that a copy of the supplementary guidance and FSN provided by Draeger Medical is included with the Babytherm® 8004/8010 user manual.
- Return FSN acknowledgment form to Draeger UK.
All healthcare workers and carers who use these devices.
Deadlines for action
Actions underway: 30 August 2016
Actions complete: 13 September 2016
If the heating element overheats, it may release hot particles, posing a potential risk of fire.
Draeger Medical UK Limited
Hertfordshire HP2 7BW
Tel: 01442 292870
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists
Trusts (NHS boards in Scotland)
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- A&E consultants
- Intensive care medical staff/paediatrics
- Intensive care nursing staff (paediatric)
- Intensive care units
- Intensive care, directors of
- Maintenance staff
- Neonatal nurse specialists
- Neonatology departments
- Neonatology directors
- Paediatric intensive care units
- Paediatric medicine, directors of
- Paediatric nurse specialists
- Paediatric surgery, directors of
- Paediatric wards
- Paediatrics departments
- Risk managers
- Special care baby units
Establishments registered with the Care Quality Commission (CQC) (England only)
- Hospitals in the independent sector
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: email@example.com and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2016/011 or 2016/006/014/291/002.
Devendra Deo and Enitan Taiwo, MHRA
Tel: 020 3080 6265
020 3080 7122
Senior Clinical Advisor
Tel: 020 3080 7128
Reporting adverse incidents in England
Alerts in Northern Ireland are distributed via the NI SABS system
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre,
Department of Health,
Social Services and Public Safety
Tel: 028 9052 386
Fax: 028 9052 3900
Reporting adverse incidents in Northern Ireland
Please report directly to NIAIC using the forms on our website.
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre,
Health Facilities Scotland,
NHS National Services Scotland
Tel: 0131 275 7575
Fax: 0131 314 0722
Reporting adverse incidents in Scotland
NHS Boards and Local Authorities in Scotland - NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland
NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Published: 2 August 2016
Issued: 2 August 2016
Alert type: Medical device alert