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Blood Pressure and Vital Signs Patient Monitor DINAMAP Pro 100 - 400 Series
Notice type:
Warning
Date:
12/03/2004
Product name or type:
Blood Pressure and Vital Signs Patient Monitor DINAMAP Pro 100 - 400 Series
Reference:
SN2004(01)
Manufacturer Or Supplier:
GE Medical Systems
Target Audience:
Health Board CEOs; Community Care Managers; Community Therapists; Health Visitors; Carers of the Elderly; Risk Managers; Loan Store Managers; Children's Disability Services; Special Schools; Educational Establishments
Problem Or Issue:
Risk of Electric Shock:
The mains input connector can be pulled out of the case exposing “live” terminals.
Background Information Or Related Documents:
The Medicines and Healthcare products Regulatory Agency (MHRA), UK received four reports on adverse incidents where the mains socket has detached from the back of the case exposing live parts. The manufacturer implemented a corrective action in August 2002 where they contacted all customers and arranged for the power socket to be glued to the rear panel. The MHRA circulated a Safety Notice MDA SN2002(34) relating to this issue in August 2002. GE Medical Ireland (formally DSL) conducted the corrective action relating to this device on the Irish market.
In 2003, a further number of incidents were reported in the UK relating to devices, which had already had the corrective action completed. As a result of this the manufacturer initiated a further corrective action in October 2003, (see MDA/2003/036 attached). GE Medical Ireland (formally DSL) is currently conducting this second corrective action in Ireland. A significant number of devices still require modification. GE Medical requests your assistance in locating and accessing these devices.
Blood Pressure and Vital Signs Patient Monitor DINAMAP Pro 100 - 400 Series Document
Actions To Be Taken:
Advise GE Medical Ireland of the number and location of all affected devices in your hospital / health board area
Ensure the modification is carried out on all affected devices
Further Information:
All adverse incidents relating to a Medical Device should be reported to the:
Medical Devices Department
Health Products Regulatory Authority
Earlsfort Centre
Earlsfort Terrace
Dublin 2
If you have any enquiries, you may contact the Medical Devices Department at:
Telephone: +353-1-6764971
Fax: +353-1-6767836
Enquiries to the manufacturer should be addressed to:
Mr. Alan Ryan
GE Medical Ireland
Unit F4
Centrepoint Park
Oak Drive
Dublin 12
Telephone: +353-1-4605500
Fax: +353-1-4605505
Email:
alan.ryan@med.ge.com
SN2004(01): Blood Pressure and Vital Signs Patient Monitor DINAMAP Pro 100 - 400 Series
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Date Printed: 19/04/2024