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EMS Medical Neonatal & Paediatric Endotracheal Tube Clamp / Holder

Notice type: Advisory

Date: 24/08/2012

  

Product name or type:
EMS Medical Neonatal & Paediatric Endotracheal Tube Clamp / Holder

Reference:
SN2012(13)

Manufacturer Or Supplier:
EMS Medical

Target Audience:
Hospital CEOs 
Maternity Units 
Paediatric Units 
Midwives 
Risk Managers 
Procurement Managers 
Loan Store Managers 
Clinical Engineers 

Problem Or Issue:
The composition of the plastic used to make the clamp/holder was changed to a DEHP-free material. This affected the physical properties of these components, resulting in an increased risk of slippage or tube obstruction. EMS Medical went into administration over one year ago before this issue was identified. 

The IMB included a copy of MDA/2012/049 in the July monthly mailing. At that time it was not known if there were any affected devices on the Irish market. The IMB now believe that some devices were supplied to Irish customers. 

Background Information Or Related Documents:
EMS Medical Neonatal Paediatric Endotracheal Tube Clamp / Holder Document

Actions To Be Taken:
The IMB advises healthcare professionals/users to: 

1. Ensure the appropriate personnel are made aware of this notice. 

2. Identify, do not use and dispose of affected devices. 

3. Inform the IMB if you have affected devices at your institution. 

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 
E-mail: devicesafety@hpra.ie
Website: www.hpra.ie 

Please click here to view PDF version of this safety notice

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