Notice Information: - Advisory - 10/09/2012

Title:

HeartStart MRx

Product:

HeartStart MRx

Reference:

SN2012(16)

Manufacturer / 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.

Issue:

There is a risk that defibrillators will not respond as intended.

Background Information / 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.

Action 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:

Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2

Telephone: +353-1-6764971
Fax: +353-1-6344033
E-mail: vigilance@imb.ie
Website: www.imb.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