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Ondal Acrobat 2000 (AC2000)

Notice type: Advisory

Date: 12/05/2011

  

Product name or type:
Ondal Acrobat 2000 (AC2000)

Reference:
SN2011(07)

Target Audience:
General Surgeons 
Theatre and Nursing Staff 
Procurement Managers 
Nursing Managers 
Consultant General Surgeons 
Hospital Managers / CEOs 
Clinical Directors 
Risk Managers 
Medical Device Distributors 
Clinical / Biomedical Engineers 

Problem Or Issue:
the Acrobat 2000 spring-loaded arms could break. The Acrobat 2000 spring arm has been used by a number of different manufacturers to support operating lights and monitors which have been placed on the market in Ireland.

Background Information Or Related Documents:
Ondal has confirmed that the affected spring arms were manufactured from January 2000 to June 2006. The affected serial numbers may be identified by the following convention:
 
                                  0111 010 XXXXX to 0111 066 XXXXX 

                       010 to 066 = month 01 / year 2000 to month 06 / year 2006 
                                        XXXXX = 5-digit serial number 

As outlined above, the Acrobat 2000 spring arm is used to support operating lights and monitors which have been placed on the market by various manufacturers. A number of manufacturers have initiated / completed field safety corrective actions in Ireland to address this issue. A listing of these manufacturers is provided below (please note that this is not an exhaustive list): 

Trumpf Medizin Systeme –Manfred Fehn Ph: +49 3671 586 41211 
Brandon Medical – Graeme Hall Ph: +44 113 277 7393 
Maquet – Gerry O’Brien Ph: + 353 1 426 0032 
Drager – Doug Sims Ph: +44 1442 213542 
Gebrüder MARTIN – Sven Zehnder Ph: + 49 7461 706 453 

The Irish Medicines Board (IMB) wishes to highlight these actions and requests that users remain vigilant for potentially affected devices in their facility.

Ondal Acrobat 2000 (AC2000) Document

Actions To Be Taken:
The IMB advises that users: 

• Identify the affected spring arms in your facility and contact the appropriate manufacturer for further guidance. 
• Follow the manufacturer’s recommendations as outlined in the associated field safety notices. 
• Users are advised to exercise caution when moving or repositioning devices connected to these spring arms pending upgrade / inspection by the 
manufacturer. 

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 


SN201107_OndalAcrobat2000_V7835_120511 - download PDF

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