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Pegasus Alternating Mattresses X2 Capacitor Upgrade Program
Notice type:
Advisory
Date:
14/03/2014
Product name or type:
Pegasus Alternating Mattresses X2 Capacitor Upgrade Program
Reference:
SN2014(10)
Manufacturer Or Supplier:
ArjoHuntleigh (Ireland) Limited
Target Audience:
Hospital CEOs
Risk Managers
Procurement Managers
Loan Store Managers
Biomedical Engineers
Nursing Managers
Nursing Staff
HSE Offices
Community Care Centres
Community Care Managers
Health Visitors
Nursing Homes
Carers
Problem Or Issue:
ArjoHuntleigh received a recent report of a failure of an internal component causing the power management unit to fail due to overheating of the component. This resulted in the evacuation of a healthcare facility as a result of smoke generated when the component failed.
Background Information Or Related Documents:
Pegasus Alternating Mattresses X2 Capacitor Upgrade Program Document
In June 2010, ArjoHuntleigh initiated a field safety corrective action to upgrade Pegasus Alternating Mattresses with Biwave, Cairwave, Trinova and Viaclin pumps, pre-2006.
This upgrade was introduced following a number of incidents relating to failure of an internal component causing power management unit failure due to overheating of a component, which could result in loss of therapy when the air pump stops and where non-toxic smoke can be emitted as the component fails.
ArjoHuntleigh has been unsuccessful in their attempts to date to locate all devices in Ireland affected by this field safety corrective action. A recent incident in Ireland of this type of failure resulted in a facility evacuation as a result of smoke generated when the component failed. There are 134 affected pumps on the Irish market, requiring an upgrade, which cannot be located.
Please see the PDF version of this Safety Notice for a least of the remaining serial numbers which remain unaccounted for.
Further details of the corrective action can be found in the attached updated field safety notice (FSN) issued by ArjoHuntleigh.
Actions To Be Taken:
The IMB recommends that users:
(1) Forward this safety notice to all those who need to be aware of this action within your organisation, including those who maintain pumps and to any other persons/organisations where these devices have been transferred.
(2) Identify the location of all affected pumps.
(3) If you / your institution have any affected pumps, please follow the manufacturer’s recommendations as outlined in the attached FSN and contact ArjoHuntleigh.
Further Information:
Enquiries to the manufacturer should be addressed to:
Rachel Dempster
ArjoHuntleigh (Ireland) Limited
EA House
Damastown Industrial Park
Mulhuddart
Dublin 15
Phone: 01-8098960
Fax: 01-8098971
Email:
rachel.dempster@arjohuntleigh.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 copy of FSN 2010
Please click here to view a copy of FSN 2014
Please click here to view a PDF version of the Safety Notice
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Date Printed: 23/04/2024