Events

Safety Alert for Maquet FLOW-i Anesthesia System C20, C30, C40

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

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
    2012-07-09
  • Event Date Posted
    2012-07-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120709.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 flow-i anesthesia system c20, c30, c40 the united states food and drug administration (fda) has issued a class i recall concerning flow-i anesthesia system c20, c30, c40, manufactured by maquet medical systems usa. this action only affected flow-i anesthesia systems distributed between may 2010 and december 2011. in specific c20, c30 and c40 flow-i anesthesia systems, if the man/auto switch was not fully engaged in either an "on" or "off position, but rather was placed in an "in- between position" for more than five seconds, a technical alarm te 613 may have been generated. activation of the technical alarm te 613 causes the system to remain in the original mode selected and does not switch the ventilation mode. to deactivate the technical alarm te 613, the system must be restarted. the corrective action associated with this field correction included upgrading the affected systems' software as well as providing new corresponding user's manuals. for details, please refer to fda website http://www.Fda.Gov/safety/recalls/ucm310815.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 9 july 2012.

Device

Maquet FLOW-i Anesthesia System C20, C30, C40
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Maquet FLOW-i Anesthesia System C20, C30, C40
  • Manufacturer
    Maquet Medical Systems USA

Manufacturer

Maquet Medical Systems USA