Events

Safety Alert for Maquet Cardiovascular Flow-i Anaesthesia System

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

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
    2016-03-07
  • Event Date Posted
    2016-03-07
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160307.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 flow-i anaesthesia system the united states food and drug administration (fda) has issued an alert concerning flow-i anaesthesia system, manufactured by maquet cardiovascular. [model numbers: c20 (for united states), c30 and c40; part numbers: 66 77 200 (united states only), 66 77 300 and 66 77 400; serial numbers: 2743, 2852, 2854, 2855, 2856, 2858] according to the manufacturer, the system is intended for use on neonatal to adult patient populations in hospital environments, except mri environment by healthcare professionals trained in inhalation anesthesia administration. electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (pcbs) that control the sub-systems. the problems manifested as multiple re-starts of the sub-systems and, in a few instances, disabling of the system has occurred. replacement pcbs are now available to correct the issues. for details, please refer to the fda website: http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-product-tabs.Cfm?action=select&recall_number=z-0804-2016&w=03022016&lang=eng posted on 7 march 2016.

Device

Maquet Cardiovascular Flow-i Anaesthesia System

Manufacturer

Maquet Cardiovascular