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Cardio Respiratory Monitors

Notice type: Advisory

Date: 12/12/2005

   

Product name or type:
Cardio Respiratory Monitors

Reference:
SN2005(05)

Manufacturer Or Supplier:
Various

Target Audience:
Risk Managers; Clinical Engineering Departments; Purchasing Managers; Nursing Managers; ICU; Theatre; Anaesthetics

Problem Or Issue:
Alarm dysfunction on cardio-respiratory monitoring systems.

Background Information Or Related Documents:
Assessment of reported incidents and near incidents relating to alarm dysfunction on cardio-respiratory monitoring systems by our colleagues in other European member states have concluded that users have an important role to play in the configuration and management of alarms on such devices.   

To date the IMB has had not been notified of any reported problems in Ireland.

Cardio Respiratory Monitors Document

Actions To Be Taken:
  • Ensure the users of these devices are made aware of this safety notice
  • Ensure that:
    • Alarm configurations are set up in accordance with your needs.
    • Alarm configurations are checked after each preventative or corrective maintenance or software upgrade.
    • Adequate and repeated training is provided to all staff using these devices.  
The development of written procedure relating to alarm management has also proven to be a useful in ensuring the good use of cardio-respiratory monitoring systems.   

Please ensure that any incidents that occur with these medical devices are reported to the IMB.

Further Information:
All adverse incidents relating to a medical device should be reported to the:   

Health Products Regulatory Authority
Medical Devices Department 
Kevin O'Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2   

If you have any enquiries, you may contact the Medical Devices Department at: 
  
Telephone:   +353-1-6764971 
Fax:             +353-1-6344033 
Email:           medicaldevices@imb.ie
Website:       www.hpra.ie

SN2005(05): Cardio Respiratory Monitors

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