Medical Device Alert: Ondal Acrobat 2000 spring arm used to support operating lights and monitors made by various manufacturers (MDA/2010/047)


Action

Ref: MDA/2010/047 | Issued: 2 June 2010 at 15:30


Document details:

Type: Medical Device Alert
Series No: MDA/2010/047
Audience: Healthcare professionals
Published: 2 June 2010 at 15:30
Format: Electronic only
Size: A4
Pages: 4
Price: Free
ISBN/ISSN:
Author:
Copyright: Crown
   

1. England


If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2010/047 or 2010/002/018/081/007

Technical aspects
Ian Patterson-Waterston or Mel King
Medicines & Healthcare products Regulatory Agency
Market Towers 
1  Nine Elms Lane
London
SW8 5NQ

Tel: 020 7084 3261 / 3286
Fax: 020 7084 3209

Email: ian.patterson-waterston@mhra.gsi.gov.uk or mel.king@mhra.gsi.gov.uk

Clinical aspects
Jonathan Plumb
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

Telephone: 020 7084 3128
Fax: 020 7084 3111

Email: jonathan.plumb@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 Central Alerting System website (external link).



2. Northern Ireland


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

Telephone: 02890 523 704
Fax: 02890 523 900

Email: NIAIC@dhsspsni.gov.uk

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

How to report adverse incidents in Northern Ireland
Please report directly to NIAIC, further information can be found on the NIAIC website (external link).
Further information about SABS can be found on the SABS website (external link).



3. Scotland


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

Telephone: 0131 275 7575
Fax: 0131 314 0722

Email: nss.iric@nhs.net

Health Facilities Scotland - Incident Reporting and Investigation Centre (external link).  



4. Wales


Enquiries in Wales should be addressed to:

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

Telephone: 029 2082 3922

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



5. Device


Ondal Acrobat 2000 (AC2000) spring arm used to support operating lights and monitors made by various manufacturers. Specific serial numbers.

These spring arms are widely used in the UK and are supplied and distributed by many companies. These companies will have added their name to the product. Additionally, these companies may have issued their own Field Safety Notices on this issue.

There are limited details of the UK suppliers, therefore the MHRA is supporting Ondal’s Field Safety corrective Action with this alert.

Only spring arms manufactured between January 2000 and June 2006 are affected. These can be identified by the serial number as shown below:

 



6. Problem


There is the potential for metal fatigue fractures on the front joint of the spring arm to occur over time. There is an internal cable which will usually support the light or monitor if the arm fractures, but the cable could break and cause injury to the patient and staff.

Ondal has issued guidance to the manufacturers that use these spring arms. Users should have been informed of this by their respective equipment supplier. A nonexhaustive list is attached. Users need to check the swing arm to establish if it has an Ondal label.



7. Action


  • Identify affected springs arms by checking the serial number.
  • Contact the supplier of the equipment, to arrange for them to inspect or replace the affected swing arm.
  • Users are advised to move lights and monitors carefully until it is confirmed that the spring arm is not affected by this action.
  • When using the arm avoid hitting other objects such as lights and the walls of laminar flow enclosures.


8. Distribution


This MDA has been distributed to:

  • NHS trusts in England (Chief Executives)
  • HSC trusts in Northern Ireland (Chief Executives)
  • NHS boards in Scotland (Chief Executives)
  • NHS boards and trusts in Wales (Chief Executives)

Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

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

  • Adult intensive care units
  • Cardiac catheterisation suites
  • Day surgery units
  • EBME departments
  • Endoscopy suites
  • Health and safety managers
  • High dependency units
  • In-house maintenance staff
  • Maintenance staff
  • Maternity theatres
  • Medical directors
  • Medical physics departments
  • Nursing executive directors
  • Paediatric intensive care units
  • Risk managers
  • Special care baby units
  • Theatre managers
  • Theatre nurses
  • Theatres
  • X-ray departments

Care Quality Commission (CQC) (England only) to:
The MHRA considers this information to be important to:

  • Hospitals in the independent sector


9. Supplier contacts


Known suppliers are:

Trumpf
Name: Alasdair Owen Telephone number: 01582 399 201

Brandon
Name: Mandy Pearson Telephone number: 0113 272 8844

Maquet
Name: Colin Moralee Telephone number: 0191 519 6200

Draeger
Name: Doug Sims Telephone number: 01442 292 868

Martin
Name: Dr Ingo Haas Telephone number: 00 49 7463 838 185

Merivaara
Name: Esko Hyvarinen Telephone number: 00 358 333 94 6186

Note: this is not an exhaustive list of suppliers. Check the swing arm to establish if it has an Ondal label.



10. Feedback


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





Page last modified: 02 June 2010