Events

Safety Alert for Humidifier

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Fisher & Paykel Healthcare Limited.

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
  • Event ID
    I1506-239
  • Event Number
    2014DM-0011418
  • Date
    2015-06-05
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=178
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer states that the referenced devices may not be able to deliver air or oxygen flows to the patient when the power line is interrupted, leading to possible adverse events on the patients.

Device

Humidifier
  • Model / Serial
    AIRVO 2 and myAIRVO 2, References PT101xx and PT100xx, serial 120521yyyyyyy until 160605yyyyyyy.
  • Product Description
    The MY AIRVO 2 is intended for the treatment of patients who breathe spontaneously and who would benefit from the administration of high-flow heated and humidified respiratory gases. Patients who have undergone surgery to receive a bypass in the upper respiratory tract would also fit within this group. The flow can be between 2 - 60 l / min according to the patient's interface. The MY AIRVO 2 should be used in patients at home or in long-term care centers. The AIR 2 is intended for the treatment of patients who breathe spontaneously and who would benefit from the administration of heated and humidified high-flow respiratory gases. Patients who have undergone surgery to receive a bypass in the upper respiratory tract would also fit within this group. The flow can be between 2 - 60 l / min according to the patient's interface. The AIRVO 2 should be used in hospitalized patients or in long-term care centers.
  • Manufacturer
    Fisher & Paykel Healthcare Limited

Manufacturer

Fisher & Paykel Healthcare Limited