Events

Safety Alert for Draeger Infinity Acute Care System in Neonatal Mode

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

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
    2013-11-06
  • Event Date Posted
    2013-11-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131106.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: draeger infinity acute care system in neonatal mode medical device manufacturer, draeger medical gmbh has issued a medical device safety alert concerning infinity acute care system (iacs) in neonatal mode using software versions vg2.0.3 and higher. it was found in a laboratory test that when a low spo2 (yellow) medium grade alarm was provoked and then paused by the user by using the alarm pause function, the device did not generate the spo2 (red) high grade life threatening spo2 low alarm on the cockpit or central station when the spo2 value was further decreased to reach the set alarm limit for the high grade life threatening spo2 alarm. the correct spo2 value was indicated on all devices and the manufacturer is not aware of any incidents during use on patient. draeger is developing a software upgrade to fix the defect. meanwhile, draeger advises the users not to pause the yellow spo2 low alarm without adequate patient monitoring. according to the local supplier, the affected products were distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 november 2013.

Device

Draeger Infinity Acute Care System in Neonatal Mode
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Draeger Infinity Acute Care System in Neonatal Mode
  • Manufacturer
    Draeger Medical GmbH

Manufacturer

Draeger Medical GmbH