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Medical Device Alert: Endres Riviera Bathlift manufactured by Drive Medical Ltd (MDA/2011/106)

Document details:

Type: Medical Device Alert
Series No: MDA/2011/106
Audience: Healthcare professionals
Published: 9 November 2011 at 14:00
Format: Electronic
Size: A4
Pages: 5
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

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CAS deadlines
Action underway: 9 December 2011, action complete: 9 February 2012

Ref: MDA/2011/106 | Issued: 9 November 2011 at 14:00

  1. England
  2. Northern Ireland
  3. Scotland
  4. Wales
  5. Device
  6. Problem
  7. Action
  8. Distribution
  9. Manufacturer contact
  10. Feedback

If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2011/106 or 2010/008/009/401/001.

Technical aspects
Ms Emma Rooke or Mrs Sara Vincent
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ

Tel: 020 3080 6609 / 7169
Fax: 020 8754 3965
Email: emma.rooke@mhra.gsi.gov.uk and sara.vincent@mhra.gsi.gov.uk

Clinical aspects
Dr Nicola Lennard
Medicines & Healthcare products Regulatory Agency
Floor 4
151 Buckingham Palace Road
London
SW1W 9SZ

Tel: 020 3080 7126
Fax: 020 8754 3965
Email: nicola.lennard@mhra.gsi.gov.uk

How to report adverse incidents

Please report via our website: Reporting adverse incidents involving medical devices.
Further information about CAS can be found on the CAS website (external link)

Alerts in Northern Ireland will continue to be distributed via the NI SABS system.

Enquiries and adverse incident reports in Northern Ireland should be addressed to:

Northern Ireland Adverse Incident Centre
Health Estates Investment Group
Room 17
Annex 6
Castle Buildings
Stormont Estate
Dundonald
BT4 3SQ

Tel: 02890 523 704
Fax: 02890 523 900
Email: NIAIC@dhsspsni.gov.uk

Northern Ireland Adverse Incident Centre (NIAIC) (external link)

Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB

Tel: 0131 275 7575
Fax: 0131 314 0722
Email: nss.iric@nhs.net

Heath Facilities Scotland Incident Reporting and Investigation Centre (IRIC) (external link)

Enquiries in Wales should be addressed to: 

Sara Hayes
Senior Medical Officer
Medical Device Alerts
Welsh Assembly Government
Cathays Park
Cardiff
CF10 3NQ

Tel: 029 2082 3922
Email: Haz-Aic@wales.gsi.gov.uk 

Bathlift: Endres Riviera pictureBathlift: Endres Riviera


Manufactured by Drive Medical Ltd.

All serial numbers are affected.

Risk of failure due to component fatigue.

The user instructions have been revised to include an estimated life expectancy for the device (page 20), improved guidance regarding frequency of required maintenance and a clarification of who is responsible for this (page 13).

The manufacturer issued a Field Safety Notice (FSN) – dated 9 August 2011 - for this device but has not had confirmation from a significant number of users that they have received and acted on this information. 

This alert has been issued in support of the manufacturer’s actions.

  • Ensure that relevant members of staff are aware of the problem.
  • Carry out the actions described in the manufacturer’s FSN, including sending confirmation requests.


Action by

All those involved in the supply, maintenance, and use of these bath lifts. In particular: equipment store managers, nursing and care home managers, occupational therapists, care staff, maintenance staff and contractors.

This MDA has been sent to:

  • NHS trusts in England (chief executives)
  • Care Quality Commission (CQC) (headquarters) for information
  • HSC trusts in Northern Ireland (chief executives)
  • NHS boards in Scotland (chief executives)
  • Local authorities in Scotland (equipment coordinators)
  • NHS boards and trusts in Wales (chief executives)
  • Primary care trusts in England (chief executives)
  • Social services in England (directors)


Onward distribution
Please bring this notice to the attention of relevant employees in your establishment. Below is a suggested list of recipients.

Trusts
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:

  • Equipment store managers
  • In-house maintenance staff
  • Maintenance staff and contractors
  • Occupational health departments
  • Occupational therapists
  • Physiotherapists
  • Purchasing managers
  • Rehabilitation engineers
  • Risk managers
  • Supplies managers


Primary care trusts
CAS liaison officers for onward distribution to all relevant staff including:

  • Equipment libraries and stores
  • Maintenance staff
  • Occupational health departments
  • Occupational therapists
  • Physiotherapists

Social services
Liaison officers for onward distribution to all relevant staff including:

  • Community care staff
  • Disability equipment stores
  • 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
  • Moving and handling co-ordinators
  • Occupational health departments
  • Occupational therapists


Independent distribution

Establishments registered with the Care Quality Commission (CQC) (England only)
This alert should be read by:

  • Care homes providing nursing care (adults)
  • Care homes providing personal care (adults)
  • Domiciliary care providers
    Hospices
  • 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 Department of Health’s Central Alerting System (CAS) by sending an email to: safetyalerts@dh.gsi.gov.uk and requesting this facility.

Paul Kendall
Drive Medical Ltd
Ainley’s Industrial Estate
Elland
West Yorkshire
HX5 9JP

Tel: 0142 231 4488
Fax: 0142 231 4481
Email: technical@drivemedical.co.uk

If you have any comments or feedback on this Medical Device Alert please email us at: dts@mhra.gsi.gov.uk

Page last modified: 09 November 2011