Events

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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Covidien Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2016-RN-00485-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-04-21
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00485-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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...
  • Modèle / numéro de série
    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
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “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