Events

Safety Alert for EnVe Ventilators

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

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
    2011-10-21
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111020.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
    Fda class i recall: carefusion enve ventilators medical device company, carefusion, recalls enve™ ventilators manufactured between december 2010 and may 2011. the fda has classified this action as a class i recall. the company identified potential risks associated with the enve ventilators. the issues include: a potential delay in resuming ventilation after reconnection; a potential automatic reset; and a potential for disconnection upon transport. failure to adequately ventilate may lead to hypoxia or hypercarbia, which may result in serious neurological injury or death. carefusion is conducting a field corrective action to update the hardware and software on affected ventilators. for details, please refer to the fda website http://www.Fda.Gov/safety/recalls/ucm276704.Htm if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

EnVe Ventilators

Manufacturer

CareFusion