Events

Safety Alert for Infant Nasal Continuous Positive Airway Pressure (CPAP) Prongs and Bubble CPAP Starter Kits

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Fisher & Paykel Healthcare Ltd.

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
    2014-04-16
  • Event Date Posted
    2014-04-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140416.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: fisher & paykel infant nasal continuous positive airway pressure (cpap) prongs and bubble cpap starter kits the australia therapeutic goods administration (tga) posted a medical device safety alert concerning infant nasal continuous positive airway pressure (cpap) prongs and bubble cpap starter kits, manufactured by fisher & paykel healthcare ltd.(fph) the manufacturer has received customer reports relating to certain lot numbers of certain models of nasal cpap prongs detaching from the fph flexitrunk nasal tubing, especially in the presence of mucous and/or moisture. in the event of the affected prongs detaching from the nasal tubing, therapy is likely to be interrupted. this may lead to a patient becoming hypoxic. the manufacturer requests customers to identify any units form the affected lot and destroy the affected prong. for details, please refer to tga website:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00437-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 april 2014.

Device

Infant Nasal Continuous Positive Airway Pressure (CPAP) Prongs and Bubble CPAP Starter Kits

Manufacturer

Fisher & Paykel Healthcare Ltd