Events

Rappel de Newport HT70 and HT70 Plus Ventilators

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-2017-RN-00467-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-04-12
  • 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-2017-RN-00467-1
  • 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
    Medtronic have received reports that newport ht70 and newport ht70 plus ventilators may reset spontaneously during normal operation, without an accompanying alarm. following the reset, the ventilator enters standby mode and will not resume ventilation without intervention. the reported incidence of the reset without alarm condition is approximately one (1) reset in every 7 million hours of ventilation. while the reports indicated that patients required transfer to another ventilator, no patient injury or impairment has been reported. there have been no reports of adverse events in australia.
  • Action
    Medtronic will provide a software update to resolve the issue, with expected availability end of May 2017. In the interim, an alternative ventilator should be used for patients who are ventilator dependent and have severe lung injury, and all other users should access alternative ventilators where possible and until the corrective actions can be implemented. If the Newport HT70 or Newport HT70 Plus ventilators are to be used, users are to ensure patients on ventilators are appropriately monitored by trained caregivers as described in Operator’s Manual and as detailed in the customer letter.

Device

Newport HT70 and HT70 Plus Ventilators

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