Events

Recall of Capnostream 20p Patient Monitors - battery pack (used for combined capnograph/pulse oximeter monitor)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Covidien 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-2016-RN-00485-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00485-1
  • 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
    Covidien respiratory and monitoring solutions, now a part of medtronic, is issuing a recall for the battery pack used in oridion labelled capnostream20p patient monitors. the scope of this recall includes battery packs that were manufactured between april 2014 and february 2016. the recall includes battery packs included with the monitors and spare replacement parts purchased separate from the monitor. this recall is due to a supplier defect in battery manufacturing that may increase the risk of thermal damage to the battery pack. there has been one report involving a fire resulting in smoke inhalation and minor burns to a user.
  • Action
    Medtronic is advising users to identify, remove and appropriately dispose of affected battery packs using the instructions provided. Alternatively, contact Medtronic with assistance with the disposal. Once the batteries are removed, the Patient Monitor must be connected to AC power and can no longer be used for intra-hospital transport of patients until replacement batteries are provided. This action has been closed-out on 28/02/2017.

Device

Capnostream 20p Patient Monitors - battery pack (used for combined capnograph/pulse oximeter moni...
  • Model / Serial
    Capnostream 20p Patient Monitors - battery pack (used for combined capnograph/pulse oximeter monitor)INTL Capnostream 20P w/prntrProduct Code: CS08658-01INTL Capnostream 20P N X1Product Code: CS08652-01Batteries manufactured between April 2014 and February 2016ARTG Number: 207165
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty Ltd
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA