Events

Rappel de Puritan Bennett 980 Series Ventilator System

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-2014-RN-01088-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-10-08
  • 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-2014-RN-01088-1
  • 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
    Normally, if the ventilator is in use and both oxygen and air gas sources are disconnected (leaving the ventilator with no supply of compressed air or oxygen for ventilation of the patient), the ventilator annunciates a high priority “no air supply” and “no o2 supply” alarm. the ventilator then enters a “safety valve open” condition. usually this is immediately recoverable when a gas supply source is reconnected. however, due to a software issue, in some cases the ventilator may transition with a “ventilator inoperative” condition upon reconnection of a gas supply source. during a “ventilator inoperative” condition, the patient is not provided ventilatory support, but may breathe room air spontaneously through the open safety valve. covidien has had no reports of serious patient injury or death associated with this issue.
  • Action
    A Covidien representative will update the software on affected ventilators as soon as possible. Customers may continue to use the ventilators during this time pending the software correction as long as two gas sources are connected to the ventilator at all times. Covidien is also providing important safety reminders in the customer letter which is described in the Puritan Bennett 980 ventilator operator’s manual. This action has been closed-out on 17/08/2016.

Device

Puritan Bennett 980 Series Ventilator System

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