Medical Device Alert: Ondal Acrobat 2000 spring arm used to support operating lights and monitors made by various manufacturers (MDA/2010/047)
Ref: MDA/2010/047 | Issued: 2 June 2010 at 15:30
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
Tel: 020 7084 3261 / 3286
Telephone: 020 7084 3128
How to report adverse incidents
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
Telephone: 02890 523 704
Northern Ireland Adverse Incident Centre (NIAIC) (external link)
How to report adverse incidents in Northern Ireland
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre
Telephone: 0131 275 7575
Enquiries in Wales should be addressed to:
Dr Sara Hayes
Telephone: 029 2082 3922
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:
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.
This MDA has been distributed to:
Care Quality Commission (CQC) (England only) to:
9. Supplier contacts
Known suppliers are:
Note: this is not an exhaustive list of suppliers. Check the swing arm to establish if it has an Ondal label.
If you have any comments or feedback on this Medical Device Alert, please email us at: firstname.lastname@example.org