Medical Device Alert

MDA/2015/021R Issued: 22 May 2015 at 16:00 Valid until: May 2016

Reissued – additional devices listed

Philips ventilators: BiPAP autoSV, BiPAP autoSV Advanced, OmniLab

Advanced, OmniLab Advanced + and HeartPAP devices

Summary
Increased risk of death for patients with a specific heart condition if being treated with Adaptive
ServoVentilation (ASV) mode on ResMed ventilators. As a result, Philips recommend the same actions are
taken while determining if this impacts their ventilators.

Action
• Be aware of Philips’s press release and ResMed’s FSN.
• Physicians: assess all patients currently being treated with autoSV ventilators for symptomatic chronic
heart failure and if necessary undertake an assessment of left ventricular ejection fraction. Where
appropriate discuss the risks and possible discontinuation of treatment with patients.
• Physicians: be aware that new at-risk patients (see background) should not use the autoSV ventilators.

Action by
• All medical staff who use these devices or who are responsible for patients with these devices.

Deadlines for actions

Actions underway: 29 May 2015
Actions complete: 09 June 2015

Device details
The specific Philips devices affected by this alert are:
• BiPAP autoSV, BiPAP autoSV Advanced, which relate to the following model numbers:
IN951S
IN951HS
IN961S
IN961HS
1042900
1042901
1008628
(and any of the above with an R in front of the number)

• OmniLab Advanced, OmniLab Advanced + and HeartPAP devices. All models.

Problem / background
ResMed undertook a study of sleep-disordered breathing in patients with heart failure (SERVE-HF clinical
trial). Preliminary analysis of this trial showed patients with chronic, symptomatic heart failure (NYHA 2-4)
with reduced left ventricular ejection fraction (LVEF ≤ 45%) and moderate to severe predominant central

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 MDA/2015/021R Issued: 22 May 2015 at 16:00 Valid until: May 2016

sleep apnoea (AHI ≥ 15) are at significantly increased risk of cardiovascular death. As a result MHRA issued
MDA/2015/020.

Philips ventilators have a similar mode and they are currently working with ResMed in order to better
understand their study data and evaluate the impact on their ventilators. In the meantime, Philips
recommends that users follow the advice in ResMed’s FSN.

Philips Respironics BiPAP autoSV/BiPAP autoSV Advanced devices are currently indicated to provide non-
invasive ventilatory support to adult patients (>30 kg/66 lbs) with obstructive sleep apnoea and respiratory
insufficiency caused by central and/or mixed apnoeas and periodic breathing. These devices are not
approved or labelled for the treatment of heart failure.

Philips will issue an FSN imminently.

MHRA is continuing to investigate this issue and may issue further advice if necessary.

Manufacturer contacts
Philips Healthcare
Contact: Steve Leonard
Tel. 0800 130 0845
Email: steve.leonard@philips.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 directors
• Adult intensive care units
• Anaesthesia, directors of
• Anaesthetic medical staff
• Anaesthetic nursing staff
• Anaesthetists
• Cardiologists
• Cardiology departments
• Cardiology nurses
• Cardiology, directors of
• Clinical governance leads
• Coronary care departments
• Coronary care nurses
• District nurses
• EBME departments
• Equipment stores
• General surgeons
• General surgery
• Health and safety managers
• Hospital at home units
• Intensive care medical staff
• Intensive care nursing staff (adult)
• Intensive care units
• Intensive care, directors of
• Medical directors

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• Medical libraries
• Medical physics departments
• Nursing executive directors
• Resuscitation officers and trainers
• Risk managers
• Supplies managers

Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
• Domiciliary care providers
• Independent treatment centres
• Nursing agencies

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/2015/021R or
2015/005/019/291/009.
Technical aspects
Louise Mulroy, MHRA
Catriona Blake, MHRA
Tel: 020 3080 7344/7219
Email: louise.mulroy@mhra.gsi.gov.uk
catriona.blake@mhra.gsi.gov.uk

Clinical aspects
Camilla Fleetcroft, MHRA
Tel: 020 3080 6097
Email: camilla.fleetcroft@mhra.gsi.gov.uk

Reporting adverse incidents in England

Through Yellow Card https://yellowcard.mhra.gov.uk/

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
Tel: 028 9052 3868
Fax: 028 9052 3900
Email: NIAIC@dhsspsni.gov.uk
http://www.dhsspsni.gov.uk/index/hea/niaic.htm

Reporting adverse incidents in Northern Ireland

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 MDA/2015/021R Issued: 22 May 2015 at 16:00 Valid until: May 2016

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
Tel: 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
Tel: 01267 225278 / 02920 825510
Email: Haz-Aic@wales.gsi.gov.uk

Reporting adverse incidents in Wales

Report to MHRA through Yellow Card https://yellowcard.mhra.gov.uk/ and follow specific advice for
reporting in Wales in MDA/2004/054 (Wales).

MHRA is a centre of the Medicines and Healthcare products Regulatory Agency, an executive agency of the Department of Health
© Crown Copyright 2015
Addressees may take copies for distribution within their own organisations

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