TransWarmer infant transport mattress, NovaPlus TransWarmer infant heat therapy mattress with WarmGel, infant heel warmer - risk of serious burn

(CooperSurgical under different brand names) Risk of serious burn if device is used past its expiry date (MDA/2015/025)

Action

  • Identify and quarantine all product that does not have a lot or expiry date on the packaging (check the transport mattress field safety notice (FSN) and heel warmer FSN.
  • Discard or return affected product to your supplier.
  • Return the relevant acknowledgement and receipt form to the manufacturer.

Action by

All staff who use these devices

Deadlines for actions

Actions underway: 20 July 2015, actions complete: 3 August 2015

Device details

Mattresses

Package label Part Product description
CooperSurgical 20421 TransWarmer® infant transport mattress
NovaPlus V6390 NovaPlus TransWarmer® infant heat therapy mattress with WarmGel®

Heel warmers

Package label Part Product description
CooperSurgical 20418 WarmGel infant heel warmer
CooperSurgical 24401 Liquid infant heel warmer
Fisher Brand 24647 FISHERBRAND gel infant heel warmer
Fisher Brand 24646 FISHERBRAND liquid infant - heel warmer
MediChoice 24649 MEDICHOICE warmgel infant heel warmer
MediChoice 24648 MEDICHOICE liquid infant - heel warmer
NovaPlus V6391 WARMGEL infant heel warmer - NOVAPLUS
NovaPlus V6393 Liquid infant heel warmer - NOVAPLUS

Manufacturer contacts

CooperSurgical
Attn: Product Surveillance
75 Corporate Dr
Trumbull CT 06611, USA
USA phone: +1 203-601-5200 ext. 3414
USA fax: +1 203-601-9870

Email: productsurveillance@coopersurgical.com

European Authorised Representative – Emergo Europe
Telephone: +31 70 346 7299

Email: vigilance@emergogroup.com

Distribution

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
  • A&E departments
  • A&E directors
  • A&E nurses
  • All departments
  • Ambulance services directors
  • Community children’s nurses
  • Community hospitals
  • Community midwives
  • Community nurses
  • District nurses
  • Gynaecologists
  • Gynaecology departments
  • Gynaecology nurses
  • Health visitors
  • Hospital at home units
  • Immunisation co-ordinators
  • Intensive care medical staff/paediatrics
  • Intensive care nursing staff (paediatric)
  • Intensive care units
  • Intensive care, directors of
  • Maternity units
  • Midwifery departments
  • Midwifery staff
  • Neonatal nurse specialists
  • Neonatology departments
  • Neonatology directors
  • Obstetricians
  • Obstetrics and gynaecology departments
  • Obstetrics and gynaecology directors
  • Obstetrics departments
  • Obstetrics nurses
  • Paediatric intensive care units
  • Paediatric medicine, directors of
  • Paediatric nurse specialists
  • Paediatric oncologists
  • Paediatric surgeons
  • Paediatric surgery, directors of
  • Paediatric wards
  • Paediatricians
  • Paediatrics departments
  • Paramedics
  • Patient transport managers
  • Phlebotomists
  • Point of care testing co-ordinators
  • Purchasing managers
  • Special care baby units
  • Supplies managers
  • Theatre managers
  • Theatre nurses
  • Theatres

NHS England area teams

CAS liaison officers for onward distribution to all relevant staff including:

  • General practice managers
  • General practice nurses
  • General practitioners

Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)

  • Clinics
  • Hospitals in the independent sector
  • Independent treatment centres
  • Nursing agencies
  • Private medical practitioners

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: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Enquiries

England

Send enquiries about this notice to MHRA, quoting reference number MDA/2015/025 or 2015/004/027/291/014

Technical aspects

Elke Kerwick or Andy Marsden
MHRA
Telephone: 020 3080 6826 / 7205

Email: elke.kerwick@mhra.gsi.gov.uk or andy.marsden@mhra.gsi.gov.uk

Clinical aspects

Mark Grumbridge
MHRA
Telephone: 020 3080 7128

Email: mark.grumbridge@mhra.gsi.gov.uk

Reporting adverse incidents in England

Through Yellow Card

Northern Ireland

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
CMO Group,
Department of Health, Social Services and Public Safety
Telephone: 028 9052 3868
Fax: 028 9052 3900

Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre

Reporting adverse incidents in Northern Ireland

Please report directly to NIAIC using the forms on our website.

Scotland

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Telephone: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Reporting adverse incidents in 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.

Private facilities providing care to private clients report to the Care Inspectorate and MHRA.

Wales

Enquiries in Wales should be addressed to:

Healthcare Quality Division
Welsh Government
Telephone: 01267 225278 / 02920 825510

Email: Haz-Aic@wales.gsi.gov.uk

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TransWarmer infant transport mattress, NovaPlus TransWarmer infant heat therapy mattress with WarmGel , infant heel warmer - risk of serious burn

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