FL14E Rose Bed - Risk of Bed Siderail Collapse - Notice to Hospitals

Starting date:

May 3, 2013

Posting date:

May 7, 2013

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

Healthcare Professionals

Identification number:

RA-28927

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

NOTICE TO HOSPITALS - Health Canada Endorsed Important Safety Information on FL14E Rose Bed

May 3, 2013

Dear Risk Management/Biomedical engineering and Health Professionals,

Please distribute to relevant departments and other involved professional staff and post this NOTICE in your institution.

Subject:     FL14E Rose Bed – Risk of bed Siderail Collapse

Stryker Canada, in collaboration with Health Canada, is providing this Notice to inform you on the risk of siderail collapse with the hospital bed - FL14E Rose Bed. It was reported that the siderail may appear latched in the upright position when it is not fully locked in place and may unexpectedly collapse if a pressure is applied on it. This failure has resulted in bruises and/or lacerations to patients who are leaning against the siderail when it collapses. Additionally, the siderail may not effectively prevent a patient from rolling or falling off the bed. Seven incidents, including three cases resulting in injuries to patients, were reported in Canada.

• There is a risk for the siderail to unexpectedly collapse as it appears to be latched in the upright position when it is not fully locked in place. This can result in bruises and/or lacerations to patients. Also, the siderail may not adequately prevent a patient from rolling or falling off of the bed.
• Personnel are advised to locate the FL14E Rose beds in their facility, ensure that the siderails have been inspected and adjusted using the attached Addendum and to continue to routinely inspect the siderails and functionality.
• Personnel are reminded to raise the siderail by its centre to prevent a premature wear of the siderail latching mechanism, which can contribute to siderail failure.

Health Canada’s Guidance Document Adult Hospital Beds: Patient Entrapment Hazards, Side Rail Latching Reliability, and Other Hazards states that rail latches should be designed so that once raised, they cannot appear to have locked in place without the latch actually being securely engaged. Stryker had established that the siderails of the FL14E Rose Bed will meet this guidance provided they are properly adjusted and have not been damaged by excessive wear.

The siderail failure may be due to a lack of proper maintenance and adjustment of the siderail as well as a premature wear of the latching mechanism caused by an excessive off-center manipulation of the siderail.

Additional Information on Installation, Adjustment and Preventative Maintenance of Rose Bed Siderails 

The attached Addendum to the Maintenance Manual provides procedures for annual maintenance to all three siderail types (full length, three-quarter length or half-length) as well as guidance on when and how to properly adjust the beds. If siderails wobble in the fully raised position or if the two hooks are not latching simultaneously, the siderails are misadjusted. Please refer to the attached Addendum for further details on how to adjust the siderails.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of siderail latching failures or any unexpected adverse incidents involving the FL14E Rose Bed should be reported 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

To correct your mailing address or fax number, contact Danielle Wyatt at 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


Attachment: Preventative Maintenance Addendum

*To contact Stryker Canada or to request a customer reply form, please call (905) 690-5733 or email CARAQA@Stryker.com.