- Medicines and Healthcare products Regulatory Agency
- 2 September 2016
- 2 September 2016
- Alert type:
- Medical device alert
Manufactured by Fisher & Paykel Healthcare Ltd – updated instructions for use to check the speaker before each use as undetected auditory alarms could result in the patient becoming hypoxic.
Identify users of the AIRVO 2 and myAIRVO 2 humidifier.
Ensure that all users receive the manufacturer’s Field Safety Notice (FSN) and that they understand the advice given by the manufacturer.
Carry out the speaker function check described in the FSN.
If the speaker is faulty, do not use the unit and contact Fisher & Paykel to arrange for the device to be replaced.
Ensure that the updated AIRVO 2 and myAIRVO 2 instructions for use are sent to all users with affected products.
Return acknowledgement form to Fisher & Paykel Healthcare Ltd.
- All healthcare workers and carers who use these devices.
Deadlines for actions
Actions underway: 23 September 2016
Actions complete: 14 October 2016
Fisher and Paykel Healthcare Ltd
Unit 16 Cordwallis Park
Telephone: 01628 626 136
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
- Adult intensive care units
- Anaesthesia, directors of
- Anaesthetic medical staff
- Anaesthetic nursing staff
- Clinical governance leads
- Community hospitals
- Equipment libraries and stores
- Equipment stores
- Intensive care medical staff/paediatrics
- Intensive care nursing staff (adult)
- Intensive care nursing staff (paediatric)
- Intensive care units
- Intensive care, directors of
- Medical directors
- Medical libraries
- Paediatric intensive care units
- Paediatric medicine, directors of
- Paediatric nurse specialists
- Paediatric wards
- Risk managers
- Special care baby units
Liaison officers for onward distribution to all relevant staff including:
- Care at home staff
- Care management team managers
- Equipment stores
- Equipment supplies managers
- In-house domiciliary care providers (personal care services in the home)
- In-house residential care homes
- Loan store managers
- Loaned equipment store managers
Establishments registered with Care Quality Commission (CQC) (England Only)
- Care homes providing nursing care (adults)
- Care homes providing personal care (adults)
- Domiciliary care providers
- 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: email@example.com and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2016/017 or 2016/006/010/299/009.
Devendra Deo and Emma Rooke, MHRA
Tel: 020 3080 6265 and 020 3080 6609
Dr Neil McGuire, Clinical Director, MHRA
Tel: 020 3080 7128 or 020 3080 6097
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 3868
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 – 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 September 2016
Issued: 2 September 2016
Alert type: Medical device alert