Static Mattresses

Notice type: Advisory

Date: 24/08/2011


Product name or type:
Static Mattresses


Manufacturer Or Supplier:
Park House Healthcare Ltd., United Kingdom

Target Audience:
Hospital Managers / CEOs 
Clinical Directors 
Risk Managers 
Purchasing Managers 
Nursing Managers 
Theatre and Nursing Staff 
Clinical / Biomedical Engineers 
Public and Private Nursing Homes 
Hospices and Community Care Centres 
Medical Device Distributors 
Members of the Public

Problem Or Issue:
Park House Healthcare has issued a field safety notice (FSN) to notify users of the availability of an updated guide to correct mattress usage.

Background Information Or Related Documents:
Park House Healthcare has indicated that mattress inspection instructions have been printed on mattress covers since December 2009. However, customers with static mattresses which predate this labelling may not be aware of the correct method to inspect mattresses. The updated guide, developed by Park House Healthcare, provides advice on how to complete these inspections correctly.

Static Mattresses Document

Actions To Be Taken:
Park House Healthcare issued a FSN and copy of the updated guide to customers who purchased mattresses within the time period 2005 – 2009. 

The Irish Medicines Board (IMB) advises that users: 

• Identify the devices in your facility, which are within the scope of this field safety corrective action (FSCA). 
• If you have devices affected by this FSCA, follow the manufacturer’s recommendations, as outlined in the attached FSN. 
• Maintain awareness of the updated guide within your facility and return the fax back form to Park House Healthcare, or your distributor, if you have not already done so 

Further Information:
Enquiries to the manufacturer should be addressed to: 

Roy Smith 
Park House Healthcare Ltd. 
Whitehall 26 Business Park 
1 Heathfield Lane 
West Yorkshire 
BD11 2HW 
United Kingdom 

Telephone: +44 845 0600 333 
Fax: +44 845 0600 334 

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 

Please click here to download copy of PDF version of Safety Notice

Medical Devices - Advisory - Static Mattresses

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