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HeartStart MRx

Notice type: Advisory

Date: 10/09/2012

   

Product name or type:
HeartStart MRx

Reference:
SN2012(16)

Manufacturer Or Supplier:
Philips Healthcare

Target Audience:
Paramedics 
Ambulance Headquarters 
Medical directors 
Risk managers 
Supplies managers 
General practitioners 
Private medical practitioners 
Clinics 
Hospitals 
Nursing Homes 

Please bring this safety notice to the attention of all who need to be aware of it.

Problem Or Issue:
There is a risk that defibrillators will not respond as intended.

Background Information Or Related Documents:
Philips has identified an issue in the HeartStart MRx monitor/defibrillator. Affected units are those used in external transport and emergency medical service environments. Accelerated wear of connector pins between paddle cables and the MRx therapy connection port may occur due to high levels of stress. Wear can prevent the device from sensing when therapy paddles are connected, or cause misidentification of external paddles. Problems can lead to a delay in therapy, incorrect energy being delivered, unintended energy discharge, shock to the caregiver, and interrupted pacing. 

The IMB is issuing this Safety Notice to ensure all HeartStart MRx users are aware of the issue. 

HeartStart MRx Document

Actions To Be Taken:
1. Ensure that all device users are aware of the information provided in the attached Field Safety Notice (FSN)issued recently by Philips. 
2. Users are instructed to carry out periodic inspections checking for signs of wear.
3. HeartStart MRx users who have detected accelerated cable wear are encouraged to remove the device from use and contact Philips without delay to arrange for a service. 
4. Therapy cables / external paddles need replacement every three years. 
5. Where possible, users should carry spare cables / paddles. 

Further Information:
Enquiries in relation to this action may be addressed to the Irish distributor: 

Cardiac Services 
128 Slaney Road 
Glasnevin 
Dublin 11 

Telephone: +353-1-8307499 
E-mail: recall@cardiac-services.com 


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 a PDF version of this Safety Notice

Please click here to view a copy of the Field Safety Notice

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