Important Safety Alerts

Health Canada has issued a medical device safety alert concerning FL14E Rose Bed, manufactured by Stryker.

Stryker Canada, in collaboration with Health Canada, is providing the safety notice to inform users 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.

The notice also attaches an addendum to the Maintenance Manual which 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. It also provides the following advice to affected users:

• 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 Addendum as attached to the safety notice 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.

For details, please visit the following Health Canada website:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/28927a-eng.php

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 08 May 2013