Events

Safety Alert for EnVe® ventilator

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
    2012-07-19
  • Event Date Posted
    2012-07-19
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120719.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: carefusion enve® ventilator the united states food and drug administration (fda) has posted a safety alert concerning enve® ventilator, manufactured between december 2010 and january 2012, by carefusion. the manufacturer had identified potential risks associated with the enve® ventilator.A leak may occur in the patient breathing circuit or the system, resulting in the ventilator not holding the set positive end expiratory pressure (peep) value either intermittently or continuously. the device will activate both audible and visual alarms to notify the health care professional that ventilation delivery to the patient may be compromised. to date, there have been no reports of patient harm associated with the affected devices. for details, please refer to the fda website http://www.Fda.Gov/safety/recalls/ucm312682.Htm. posted on 19 july 2012.

Device

EnVe® ventilator

Manufacturer

CareFusion