Events

Recall of SoKINOX NO (Nitric Oxide) Delivery and Monitoring System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Maquet Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-00851-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-07-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00851-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Getinge has identified an issue where during no (nitric oxide) therapy, when a no cylinder runs nearly empty the system will indicate this by the "almost empty cylinder" icon. when the cylinder runs empty it will then trigger the alarm no cylinder 1 missing (or empty) or no cylinder 2 missing (or empty). this is indicated on the user interface by a crossed out cylinder icon. the system automatically shifts over to the other cylinder.Due to a pressure increase after the cylinder switch-over there are two possible issues identified:1. the cylinder status icon can change and erroneously indicate remaining gas in an empty no gas cylinder.2. the alarm “no cylinder 1 missing (or empty)” or “no cylinder 2 missing (or empty)” can be deactivatedif the empty no cylinder is not replaced, both no cylinders can run empty and cause a stop in no delivery. to date, there have been no reports of patient injury as a result of this issue.
  • Action
    Getinge/Maquet will initiate an immediate update of all affected SoKINOX systems as soon as the system version 1.3 is released in Australia. Once version 1.3 available, customers will be contacted by a Getinge/Maquet sales or service representative to plan for the update of the device.

Device

SoKINOX NO (Nitric Oxide) Delivery and Monitoring System
  • Model / Serial
    SoKINOX NO (Nitric Oxide) Delivery and Monitoring SystemDevice Number: 66 94 550ARTG Number: 273803
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA