Exact Couch Top
Notice type: Warning
Date: 20/04/2009
Product name or type:
Exact Couch Top
Reference:
IMB Safety Notice SN2009(01)
Manufacturer Or Supplier:
Varian Medical Systems
Target Audience:
Chief Executive Officer
Director of Radiology
Radiographers
Radiologists
Risk Managers
Clinical Engineering
Supplies / Purchasing Manager
Problem Or Issue:
The potential for patients and healthcare professionals to be injured by catching their fingers at various pinch-points on the Exact couch top. A number of incidents occurred since the distribution of a field safety notice (FSN) highlighting the issue.
Background Information Or Related Documents:
This safety notice relates to all machines fitted with the Exact couch top, whether equipped with an Exact Couch or the ETR couch with Exact Couch top upgrade. This will include both low and high energy C-Series Clinacs, Acuity and Ximatron product lines.
Varian Medical Systems advised the Irish Medicines Board (IMB) of an issue they discovered with the Exact couch top. They identified several locations on the couch that can cause severe injuries to staff and patients when in use. There have been a number of injuries reported to date, as a result of which Varian Medical Systems initiated a field safety corrective action.
There are several locations on the underside of the Exact couch top that could present a pinch hazard. Three main points that a user should be aware of:
- Port film clip/lateral carriage intersection
- Couch magnet mechanism / lateral carriage intersection
- Couch top box section / lateral carriage intersection
Reference Appendix 1 for the FSN (reference CP-00019) supplied by Varian Medical Systems for further information.
Varian Medical Systems distributed a FSN in August 2008 to all hospitals / clinics they had identified as being affected by this issue. An updated FSN was distributed in March 2009 that included additional devices that had not been included in the original FSN. This updated FSN was only distributed to the hospitals / clinics where the additional devices were located.
Since the distribution of the original FSN in August 2008, there have been further incidents in hospitals/clinics that had received the FSN.
To date there have been no incidents reported in Ireland. The modifications for all affected devices in Ireland are scheduled for completion by the end of July 2009.
Exact Couch Top Document
Actions To Be Taken:
- Ensure that FSN (reference CP-00019) supplied by Varian Medical Systems is circulated to all users of the Exact couch top.
- Report any incidents to the IMB.
Further Information:
All adverse incidents relating to a medical device should be reported to the:
Health Products Regulatory Authority
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Telephone: +353-1-6764971
Fax: +353-1-6344033
Enquiries to the manufacturer should be addressed to:
Varian Medical Systems UK Limited
Gatwick Road
Crawley RH10 9RG
United Kingdom
Telephone: +44-1293-531244
E-mail: onc.helpdesk@varian.com
IMB Safety Notice SN2009(01): Exact Couch Top
Appendix 1 of IMB Safety Notice SN2009(01): Exact Couch Top
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