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Corona Medical Bed Side Rails – 1025, 1031 & SP 1027 Range
Notice type:
Advisory
Date:
28/11/2011
Product name or type:
Corona Medical Bed Side Rails – 1025, 1031 & SP 1027 Range
Reference:
SN2011(29)
Manufacturer Or Supplier:
Corona Medical
Target Audience:
Hospital Managers / CEOs
Risk Managers
Purchasing Managers
Loan Store Managers
Community Care Managers
Nursing Homes
Problem Or Issue:
Corona Medical Bed Side Rails – 1025, 1031 & SP 1027 range are not compliant with the dimensional requirements of the applicable standards, which defines the minimum size and / or maximum areas with risk of trapping in an adult bed for medical use. These side rails require replacement.
Background Information Or Related Documents:
Corona Medical issued a field safety notice (FSN) to their customers in March 2009. Corona Medical are recommending that these side rails are replaced as they are not compliant with the required standards.
The location of all the affected products in Ireland has not been identified as these products were placed on the Irish market in 2000 and 2001 and traceability is limited. All relevant information relating to this action can be found in the attached FSN issued by Corona Medical.
The IMB issued a safety notice in June 2010 highlighting the risk that occupants may become entrapped in the side rails/mattresses of hospital beds/cots, potentially resulting in harm, including death. The safety notice, SN2010(05), is available on the website.
Corona Medical Bed Side Rails – 1025, 1031 SP 1027 Range Document
Actions To Be Taken:
Corona Medical and MMS Medical have been unsuccessful in their attempts to date to locate all devices in Ireland affected by this field safety corrective action.
The IMB advises that users:
1. Ensure the appropriate personnel are made aware of this notice.
2. Identify the location of all affected side rails.
3. Determine if you / your institution have medical devices affected by this issue.
4. If you / your institution have affected medical devices, follow the manufacturer’s recommendations as outlined in the attached FSN and ensure that corrective action is completed on all affected medical devices.
Further Information:
Enquiries to the manufacturer should be addressed to:
Stephane Champigny
Za La Fosse Neuve
Route de Meslay
37210 Parcay Meslay
France
Telephone: +33-247-885-875
Fax: +33-247-885-811
Email:
s.champigny@corona-medical.com
Enquiries to the distributor should be addressed to:
Rose Gilbert
MMS Medical Limited
51 Eastgate Drive
Little Island
Cork
Telephone: 021-4618000
Fax: 021 461 8099
Email:
info@mmsmedical.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:
vigilance@imb.ie
Website:
www.hpra.ie
Please click here to download a PDF version of this Safety Notice
Please click here to download a copy of the field safety notice
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Date Printed: 25/04/2024