Events

Safety Alert for FL14E Rose Bed

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Stryker.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-05-08
  • Event Date Posted
    2013-05-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130508b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: stryker fl14e rose bed 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.

Device

FL14E Rose Bed
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Stryker FL14E Rose Bed
  • Manufacturer
    Stryker

Manufacturer

Stryker
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DH