AlterG Anti-Gravity treadmill, model M320, used for rehabilitation after surgery – unexpected surge to maximum speed and failure of the emergency stop

Risk of injury to the patient if the treadmill suddenly goes to top speed.

Action

  • Identify all affected devices – see the manufacturer’s Field Safety Notice (FSN) dated 26 June 2017.

  • Contact the distributor to acknowledge receipt of the FSN and to arrange for the lower motor controller board to be replaced as soon as possible.

Action by

Medical and technical staff involved in the use and maintenance of these devices.

Deadlines for actions

Actions underway: 18 January 2018

Actions complete: 12 April 2018

Device details

Treadmills built before 06/06/2016 and with serial numbers lower than M300-1117 are affected.

Distributor contacts

Trevor Donald
SportsMed Products Ltd
Tel: 07891 251503

Email: trevor@sports-medical.co.uk

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:

  • Biomedical engineering staff
  • Cardiology departments
  • Cardiac laboratory technicians
  • Cardiologists
  • EBME departments
  • Equipment libraries and stores
  • General surgery
  • Maintenance staff
  • Occupational therapists
  • Physiotherapists
  • Rehabilitation engineers
  • Risk managers

Independent distribution

Establishments registered with OFSTED

  • Hospitals in the independent sector
  • Independent treatment centres

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/2017/037 or 2017/006/027/291/023.

Technical aspects

Andy Marsden, MHRA
Tel: 020 3080 7205

Andrew.Marsden@mhra.gov.uk

Clinical aspects

Devices Clinical Team, MHRA
Tel: 020 3080 7274

DCT@mhra.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

Tel: 028 9052 3868

Email: niaic@health-ni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC)

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

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: 02920 823 624 / 02920 825 510

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

Reporting adverse incidents in Wales

Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).

Download documents

MDA/2017/037 - AlterG Anti-Gravity treadmill

Published 21 December 2017