Events

Safety Alert for Trilogy 100 Ventilators

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

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
    2012-01-13
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120113.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: respironics trilogy 100 ventilators the food and drug administration (fda), united states, has issued a class i recall on respironics trilogy 100 ventilators. trilogy 100 ventilators are being recalled due to a manufacturing issue. this issue can cause part of the blower that circulates air and other gases through the ventilator to move out of position and cause the device to alarm and stop delivering therapy to the patient. in the event of a blower failure, the ventilator will stop delivering therapy and a high priority alarm will sound to alert the caregiver to immediately respond. failure to respond could result in the potential for harm or death of a ventilator-dependent patient. according to the local supplier, the affected product is not distributed in hong kong. for details, please visit the following fda website: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm287528.Htm. if you are in possession of the product, please contact your supplier for necessary actions.

Device

Trilogy 100 Ventilators

Manufacturer

Respironics
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    DH