IntelliVue MX40 patient-worn monitors – increased power consumption and no visual or audible alarms when batteries are low (MDA/2019/025)
Manufactured by Philips – devices may lose power earlier than expected and users may not realise the loss of monitoring due to no alarm, which could contribute to a delay in emergency treatment.
Action
- Locate all IntelliVue MX40 devices (see manufacturer’s updated Field Safety Notice (FSN) issued 19 June 2019)
- Contact the manufacturer to arrange for them to update the software to version B.06.59 if this hasn’t already been done
-
Until the software has been upgraded:
- devices being used in Monitor Mode, with SpO2 measurement (Manual, Continuous and Auto modes) and with AA batteries as the power source, should have their batteries replaced every 2 hours
- devices used in all other modes and/or with rechargeable battery packs should have their batteries/packs replaced every 8 hours
- as specified in the instructions for use, all power sources should be fully charged before starting to use the device
- Report suspected or actual adverse events involving these devices through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.
Action by
All medical, nursing and technical staff involved in the use and maintenance of these devices.
Deadlines for action
Actions underway: 23 July 2019
Actions complete: 13 August 2019
Medical Device Safety Officer (in England)
Ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.
Remember: if your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.
Device details
All MX40 units are affected. The original expected battery life can be found in the instructions for use, section 15. This performance will be restored once the software is upgraded.
See .
You can check which software version is installed on each monitor by touching the battery icon on the main screen, then selecting ‘Device Info’. The software version is listed under ‘Appl SW’.
See showing how to check the software version.
Manufacturer contacts
Philips Customer Care Service Centre
Tel: 0870 532 9741
DeviceVigilanceUKI@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 NICAS 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
- Anaesthetists
- Cardiac laboratory technicians
- Cardiac pacing technicians
- Cardiologists
- Cardiology departments
- Cardiology nurses
- Cardiology, directors of
- Cardiothoracic departments
- Cardiothoracic surgeons
- Cardiothoracic surgery directors
- Community hospitals
- Coronary care departments
- Coronary care nurses
- Day surgery units
- EBME departments
- Equipment stores
- Equipment libraries and stores
- General surgery
- General surgical units, directors of
- In-house maintenance staff
- 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
- Midwifery departments
- Midwifery staff
- MRI units, directors of
- Neonatal nurse specialists
- Neonatology departments
- Neonatology directors
- Operating department practitioners
- Ophthalmic nurses
- Outpatient theatre managers
- Outpatient theatre nurses
- Paediatric intensive care units
- Paediatric medicine, directors of
- Purchasing managers
- Radiation & medical oncology departments
- Radiographer superintendents
- Renal medicine departments
- Renal medicine, directors of
- Resuscitation officers and trainers
- Special care baby units
- Theatre managers
- Theatre nurses
- Theatres
Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
- Hospitals in the independent sector
- 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 Central Alerting System (CAS) by sending an email to: safetyalerts@mhra.gov.uk and requesting this facility.
Enquiries
England
Send enquiries about this notice to MHRA, quoting reference number MDA/2019/025 or 2019/004/011/291/024.
Technical Aspects
Phillip Davenport, MHRA
Tel: 020 3080 6000
Clinical Aspects
Devices Clinical Team, MHRA
Tel: 020 3080 7274
To report an adverse incident involving a medical device in England use the Yellow Card reporting page.
Northern Ireland
Northern Ireland Adverse Incident Centre (NIAIC)
CMO Group
Department of Health, Social Services and Public Safety
Tel: 028 9052 3868
To report an adverse incident involving a medical device in Northern Ireland use the forms on the website.
Alerts in Northern Ireland are distributed via the NICAS system.
Scotland
Incident Reporting and Investigation Centre (IRIC)
Health Facilities Scotland
NHS National Services Scotland
Tel: 0131 275 7575
To report an adverse incident involving a medical device in Scotland, email IRIC to request a webform account.
For more information, or if you can’t access the webform, visit the website: how to report an adverse incident.
Wales
Population Healthcare Division, Welsh Government
Tel: 03000 250 986 / 03000 255 510
To report an adverse incident involving a medical device in Wales, use the Yellow Card reporting page and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).
Download document