Events

Safety Alert for Ondal AC2000 Spring-Loaded Arm

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

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
    2014-04-01
  • Event Date Posted
    2014-04-01
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140401.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: draeger ondal ac2000 spring-loaded arm the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning ondal ac2000 spring-loaded arm, manufactured by draeger and up until the end of 2006. the affected part numbers are g19051, g19262, g93358 and g93359. the manufacturer has received case reports where a welded seam in the spring-loaded arm of the monitor holder broke. investigations revealed that the welded seam in the spring-loaded arm was unable in isolated cases to withstand the dynamic stress over years where monitors were frequently moved. the monitor is then at risk of falling. although no injury was reported, the risk of injury to persons positioned beneath the monitor cannot be excluded. the manufacturer advises users that monitors in the affected installations must not be positioned above people and that monitors must be moved with care (e.G. holding monitor in both hands) until the replacement has been carried out. in particular, monitors should not be positioned with considerable force – the stress on the lower joint of the spring-loaded arm should be minimized. the manufacturer would arrange replacement of the affected spring-loaded arm. for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con394667 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 01 april 2014.

Device

Ondal AC2000 Spring-Loaded Arm
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Draeger Ondal AC2000 Spring-Loaded Arm
  • Manufacturer
    Draeger

Manufacturer

Draeger