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LIFEPAK CR Plus and LIFEPAK EXPRESS
Notice type:
Advisory
Date:
17/05/2013
Product name or type:
LIFEPAK CR Plus and LIFEPAK EXPRESS
Reference:
SN2013(05)
Manufacturer Or Supplier:
Physio-Control, Inc.
Target Audience:
Paramedics
Emergency Medical Technicians
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:
Physio-Control has identified an issue with the LIFEPAK CR Plus and LIFEPAK Express automated external defibrillators (AEDs). In certain instances, a devices replaceable CHARGE-PAK battery charger has not lasted the approximate two year lifespan due to an internal electrical failure that causes early internal battery depletion. Problems can lead to the device not being ready for use when required.
The Irish Medicines Board is issuing this Safety Notice to ensure all LIFEPAK CR Plus and LIFEPAK Express AED users are aware of the issue.
LIFEPAK CR Plus and LIFEPAK EXPRESS 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 Physio-Control.
2. Users are instructed to carry out periodic inspections checking the readiness Indicator.
3. Users who have devices showing anything but the “OK” symbol are encouraged to contact Physio-Control without delay to determine the next steps.
Further Information:
Enquiries in relation to this action may be addressed to the UK / Ireland distributor:
Katie Long
Oxygen Care Ltd
2 Holfeld Business Park
Kilmacanogue
Co. Wicklow
Telephone: +353-1-2769700
Fax: +353-1-2764970
E-mail:
klong@oxygen-care.ie
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
Click here to view a copy of the field safety notice
Click here to view a PDF version of this Safety Notice
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Date Printed: 26/04/2024