Events

Safety Alert for Engstrom Carestation

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

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
    2015-02-09
  • Event Date Posted
    2015-02-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150209.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: datex-ohmeda engstrom carestation health canada posted a medical device safety alert concerning engstrom carestation manufactured by datex-ohmeda inc. the affected model is 1505-9000-000 and the affected lot numbers are cbcp01415, cbcp01452 and cbcp01475. specific combinations of engstrom ventilator casters and bases have been identified that pose an increased likelihood of failures of the caster mounting hardware. a failure of the caster mounting hardware may result in the ventilator falling/tipping (overbalancing) which can result in serious injury to patients or staff. for details, please refer to the following link: http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2015/43635r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 9 february 2015.

Device

Engstrom Carestation
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Datex-Ohmeda Engstrom Carestation
  • Manufacturer
    Datex-Ohmeda Inc

Manufacturer

Datex-Ohmeda Inc