Events

Safety Alert for FLOW-i Anaesthesia System

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

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
    2015-06-22
  • Event Date Posted
    2015-06-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150622a.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: maquet cardiovascular llc flow-i anaesthesia system the united states food and drug administration (fda) has issued a medical device safety alert concerning flow-i anaesthesia system, manufactured by maquet cardiovascular llc. in some flow-i anesthesia systems, patient cassette can get dislodged which could result in gas leakage within the system internal circuit potentially leading to a stop in ventilation. for details, please refer to the fda websites: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-1706-2015&w=06172015&lang=eng if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 june 2015.

Device

FLOW-i Anaesthesia System

Manufacturer

Maquet Cardiovascular LLC