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 
Email:            vigilance@imb.ie 
Website:        www.hpra.ie


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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