FL14E Rose Bed - Risk of Bed Siderail Collapse - For the Public

Starting date:

May 7, 2013

Posting date:

May 7, 2013

Type of communication:

Public Communication

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-28935

This is duplicated text of a letter from Stryker Canada. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

PUBLIC COMMUNICATION - Health Canada Endorsed Important Safety Information on FL14E Rose Bed

May 7, 2013

Subject: FL14E Rose Bed – Risk of bed Siderail Collapse

Stryker Canada, in collaboration with Health Canada, has issued a Notice to Hospitals regarding the Rose Bed, a hospital bed used in healthcare facilities. It was reported that the siderail may appear latched in the upright position when it is not fully locked in place and may suddenly collapse if a pressure is applied on it. This failure has resulted in bruises and/or cuts to patients who are leaning against the siderail when it collapses. Additionally, if this failure occurs, the siderail may not prevent a patient from rolling or falling off the bed.

• There is a risk for the siderail to suddenly collapse as it appears to be latched in the upright position when it is not fully locked in place. This failure can cause bruises and/or cuts to patients. Also, the siderail may not adequately stop a patient from rolling or falling off of the bed.
• Users are reminded to raise the siderail by its centre to prevent a premature wear of the siderail latching mechanism, which can contribute to this failure.

The Notice to Hospitals provided more technical information to healthcare professionals on when and how to perform the preventative maintenance of the side rails to correct this failure. (http://www.stryker.ca/)

You should report any incidents involving the Rose bed to Stryker Canada or to Health Canada at the following addresses:

Stryker Canada
45 Innovation Drive, Hamilton, ON L9H 7L8
Fax: (905) 690-5733
Email: CARAQA@Stryker.com

Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: The Inspectorate Hotline 1-800-267-9675

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada Web site.

For other medical device inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

Yours truly, 

original signed by

Danielle Wyatt
Regulatory Affairs Assoc