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 to see where the expiry date should be.
- 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
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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